Arrow Right. Questions? PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. Contact us at 800-323-4040 or accred@cap.org. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. 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. Why are we making this change? July 2018Take the new ASCO/CAP guideline for HER2 testing. This is not just another guideline. Harris S. Goodman, MD, Checklists Committee chair and clinical laboratory director, Alameda Health System Highland Hospital, Oakland., Calif., says GEN.20318 underscores that there is no point in taking actions that do not accomplish anything. Possibly the action taken is applied to a problem you thought was present, though all the while it was another problem that was present and causing problems. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. They are available in different checklist types and formatting options, . What if patients call the number and no one records their complaints? 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. Newswise Northfield, ILThe College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. Addition of deficiencies cited on previous inspections (including the requirement number, inspection date, and inspector comments) in the inspector version of the checklists. On the other hand, not every head and neck case requires it. 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. CAP requirements commonly exceed the standards, bolstering patient care and safety. Were closing the loop on quality management wherever we can, Dr. Sarewitz says. 1. Everybody wants to do this, Dr. Rutledge continues. Learn more about the webinar and register. April, 2020 . We dont want any fear of whistleblower blowback in labs. October 2019Histocompatibility laboratories that provide services for cellular therapy transplant patients have one more inspection option to consider, thanks to a new edition of the CAPs histocompatibility checklist released in September. @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 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. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> 2 0 obj GEN.20326 Assessment of the QM Program Implementation is a revised requirement that existed previously as GEN.16902 QM Program Implementation. GEN.20326 says that in any lab that has been CAP accredited for more than 12 months, the QM program must be implemented as designed and assessed at least annually for effectiveness. August 2018The CAP and the Centers for Medicare and Medicaid Services reached an understanding earlier this year on how adequacy assessments and rapid on-site evaluations in cytology can be accounted for without causing undue impact on workload limits. 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. People who are on the line doing the testing may see something that is the start of an important issue. For more information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients who trust them with their care. There are several reasons why it could happen, he says. 3 0 obj 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. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. All rights reserved. In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. 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. When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. Sample adequacy allows for a single visit and avoids having to make multiple attempts to provide material sufficient for all required testing, including flow cytometry, microbiology, cell block preparation for immunohistochemical and histochemical staining, and molecular testing. Licenses and Certificates. 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. Tag Archives: CAP lab accreditation/checklists/protocols/guidelines, CAP lab accreditation/checklists/protocols/guidelines, Do you have a question related to pathology and laboratory medicine practice? If you purchase the accreditation checklists and apply for accreditation within 6 months of purchase, well waive the accreditation application fee. 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. Laboratories have seen lower gynecologic volumes and an increase in both nongynecologic fine-needle aspiration biopsy and touch imprint samples. Visit cap.org to register. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). Written has been removed and it now says a lab must have a QM program. 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. Arch Pathol Lab Med. The CAP expects to release its 2022 CAP checklist edition in October. 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. Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. xZn8}TiNE4]"@>x1]%Q7ZB E5au,nv?-n~X-vy^ow]?Hq9G7Onv%A7tEo?^!WB(,3aXDL3h&1ch]|~#ld8Hk8Tn ''psn(00AR -?-+PPtyPa(SPp158g Sc3USSvCMO i@p310jxKh1]N8.x'SkdxEN0~mS]lC2Dp, (*yyk$rAEF~]>.t}uZB@I7 y.V4YrOPl*aT:tgD!zgEF#.8{ The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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 CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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. 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. % 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. They are the leading source of disparities between the findings of the programs inspectors and inspection audits done by the Centers for Medicare and Medicaid Services. Its been fantastic, he says. Streamline management and compliance of CAP accreditation checklist requirements through the use of a software solution from one of the program participant vendors. 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. There are other tests that are done redundantly, excessively, and are noncontributory to good patient care. Read the CAP Annual Report. 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. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. In GEN.16902, QM programs needed only to be reviewed, not assessed. The focus of what is now an annual assessment has been expanded beyond simply evaluating the performance of the quality indicators to also evaluating other aspects of the QM program, such as follow-up on non-conforming events that require corrective/preventive action and actions taken to address concerns about quality and safety. 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. 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. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. For questions about the use of the Checklists or Checklist interpretation, email accred@cap.org or call 800-323-4040 or 847-832-7000 (international customers, use country code 001). Highlights of the checklist enhancements include: These new features will be available for use starting with the 2022 Checklist edition. Read theCAP Annual Report. But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last years checklists. 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. NORTHFIELD, Ill.The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. Mpox a Cause for Concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Black Caucus. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. 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. 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). August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. About the College of American Pathologists. "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. These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist For the purposes of clarity, this requirement was added and includes ISO concepts, the point being that not only does a laboratory have to record corrective and preventive actions taken for non-conforming events and quality indicators that do not meet targets, but the lab also must evaluate how effective its corrective and preventive actions are. 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