This challenge is unprecedented in scope. Skip to main content. Good Clinical Laboratory Practice (GCLP)/08 | 3 Good Clinical Laboratory Practice Guidelines is now published by WHO/TDR under the terms of an agreement between WHO and BARQA. NEW Checklist Questions Question Effective Date MIC.00005 09/27/2007 MIC.32518 09/27/2007 MIC.32556 09/27/2007 MIC.32594 09/27/2007 MIC.32632 09/27/2007 MIC.32670 09/27/2007 I develop the knowledge, skills, professional attitude, and values in the performance of clinical laboratory procedures needed to help the physician in the proper diagnosis, treatment, prognosis, and prevention of diseases; 5.32 acquire critical thinking skills in Medical Technology/Medical Laboratory “If you’re sitting with a team discussing state-of-the-art biomarker testing in lung cancer, for example, you can come to the team as a general pathologist, and that’s certainly OK, but think how much better it would be if the pathologist, the oncologist, the surgeon, and everyone else at the table focuses on lung cancer and has insight and up-to-date knowledge of that disease,” Dr. Khoury says. Manage your lab’s competency assessment Learn More . For the past 10 years, this has been accomplished thanks to the network’s structure of affiliates—designated as certified, associate, or partner members differentiated by their level of clinical integration and collaboration. If you are enrolled in the CAP's Laboratory Accreditation Program and are preparing for an inspection, you must use the Checklists that were mailed in your application or reapplication packet, not those posted on the Web site. AMR is used as part of the CAP checklists to satisfy the CLIA ’88 requirements for the term ‘calibration verification’. Building bonds with like-minded institutions is essential to the fulfillment of The University of Texas MD Anderson Cancer Center’s mission to end cancer. Built into each of these processes are quality elements and metrics. Our Duke University Health System Clinical Laboratories are College of American Pathologist (CAP) accredited, CLIA certified, state of the art, multidisciplinary labs. 1) Are cleared by FDA for home use; 2) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or 3) Pose no reasonable risk of harm to the patient if the test is performed incorrectly. Dr. Khoury and the network team, along with their counterparts at partner sites and other affiliates, identify areas of need and opportunity on which they want to focus and help their affiliate become a leader in a particular marketplace. 301-215-6525 . Northfield, IL, 2005 [50]C ollege of A merican P athologists Quality management in anatomic pathology CAP. MD Anderson operates with three guiding principles when it comes to cancer care, across Houston and across its network of affiliates: 1) disease-focused multidisciplinary care, 2) consistency through evidence-based algorithmic approaches, and 3) a robust, ongoing quality management program. •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 ANAB provides laboratory accreditation to ISO 17025 and multiple standards in many industry-specific programs. ANAB believes in a partnership approach to laboratory accreditation assessments. Good Clinical Laboratory Practice (GCLP)/08 | 3 Good Clinical Laboratory Practice Guidelines is now published by WHO/TDR under the terms of an agreement between WHO and BARQA. We use an independent review process for guideline and guideline revision approval. Click on Laboratory Accreditation, Checklists, and then click the column marked Changes for the particular checklist of interest. For organizations asking how to improve the quality of their products and services and consistently meet their customers’ expectations, ISO has an answer. Licenses and Accreditation CLIA Compliance and CAP Proficiency Testing. Laboratory Professionals Learning Programs. The CAP Laboratory Accreditation Program is an internationally recognised program based on rigorous accreditation standards, covering a complete array of disciplines and testing procedures, whereby helps in achieving a consistently high level of service throughout the institution and the healthcare system. Transforming world society and the world’s economy to a sustainable basis is the most significant challenge of our time. Fax: (301) 215-5725 . Registration. 6 Host Inspection Day with the same customized checklists that you received CDC, in partnership with CMS external icon and FDA external icon, supports the CLIA program and clinical laboratory quality. The four laboratory accreditation programs are all created with the primary objective of improving the quality of clinical laboratory services. The CAP's peer-based inspector model provides a unique balance of regulatory and educational coaching supported by the most respected worldwide pathology organization. For 70 years, the CAP has fostered excellence in laboratories and advanced the practice of pathology and laboratory science. Reproducibility 6. Accreditation in Canada: This event is an Accredited Self Assessment Program (Section 3) as defined by the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada, approved by the Canadian Association of Pathologists - … Laboratory Accreditation Program Audioconference, January 20, 2010 Accreditation Requirements for Waived Vs. Nonwaived Tests Rawhi Omar, MD, PhD, FCAP State Commissioner, Kentucky ©2010 College of American Pathologists. The CAP’s accreditation programs offer: Help towards continuous compliance Confidence in the accuracy of clinical reports Improved risk management Access to best practices The right to display the CAP Accreditation Mark Facilities that choose any of the CAP accreditation programs also receive access to a … If you are enrolled in the CAP's Laboratory Accreditation Program and are preparing for an inspection, you must use the Checklists that were mailed in your application or reapplication packet, not those posted on the Web site. The second semester of the fourth year level is the internship program of six (6) months in an accredited training laboratory with The Checklists undergo regular revision and Checklists may be revised after you receive your packet. Objectivity and impartiality 4. Collaboration is a key tenet of health care. To develop and implement effective methods for identifying, reviewing, MD Anderson developed standardized processes that start from patient intake and extend throughout their patient’s journey with cancer and into survivorship. Learn about and apply for CAP laboratory accreditation programs. Laboratory Quality Management System 5 Foreword Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. 3. The Principles include a Schedule that lists accreditation materials (or the standards) that relate to the actual process. American Association for Laboratory Accreditation 5202 Presidents Court, Suite 220 Frederick, MD 21703 . Once these areas are identified, the pathologists are encouraged to become second-opinion resources for their team and to spend a sizeable amount of their continuing medical education on their focus area or areas. the CAP website. OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING Number 1 OECD Principles on Good Laboratory Practice (as revised in 1997) 61011 Document complet disponible sur OLIS dans son format d’origine Complete document available on OLIS in its original format Unclassified ENV/MC/CHEM(98)17 Or. So, depending on the institution’s needs, the practice’s pathology structure and volume, and the training background of the pathologists, they might select one, two, or sometimes three disease areas (eg, breast, lung, or gastrointestinal cancers) as declared subspecialty focus areas. CAP Laboratory Accreditation Program GOAL: To improve the quality of clinical labo ratory services, and ensure the accuracy and reliability of test results through an ed ucational and peer review inspection process. The third main guiding principle for MD Anderson and its affiliates is quality. Secondly, Dr. Khoury and his colleagues focus on pathology and laboratory logistics and processes so that “patients are managed along predictable but appropriately nimble algorithms,” he says, allowing patients to be properly diagnosed and treated, regardless of when they come in or which physician happens to have a hand in their care. Manage rapidly evolving changes in laboratory medicine and technology Note: In order to register, your account must be affiliated with the laboratory participating in the CAP Surveys program. Get more information about CARA ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. Laboratory Professionals Learning Programs. Laboratory professionals access point to a variety of learning opportunities created to support your needs. principle in a new world order, a piecemeal approach—emphasizing some aspects, while neglecting others—is unlikely to yield effective, lasting results. 5.6. … 301-644-3248 For pathology and the medical laboratory, it requires the pathologist’s oversight and expertise to ensure that patient samples are handled along standardized procedural guidelines that establish testing consistency and accuracy. A laboratory must have persons in its organization who have the authority to execute specific functions within its overall scope of work—and can demonstrate accountability for their results. The College of American Pathologists (CAP) uses Analytical Measurement Range (AMR) as part of their checklist for their Laboratory Accreditation Program. Our Pathology and Laboratory Quality Center for Evidence-based Guidelines (Center) develops guideline recommendations by following the National Academy of Medicine's Standards for Developing Trustworthy Clinical Practice Guidelines to ensure transparency and reduce bias. IMPORTANT: To claim credit and fulfill the inspection team leader training requirement, you must pass the post-test. Program, but rather complements CAP accreditation and other quality systems by optimizing processes to improve patient care, strengthen deployment of quality standards, mitigate risk, and control costs. Standards for CAP Accreditation The specifics of how the Standards are applied to laboratories are found in the CAP Accreditation Checklists and Terms of Accreditation. Main Hospital Clinical Laboratory +92 21 111 911 911 Main Hospital Blood Bank ... Because Patient Safety is at the core of AKUH’s guiding principles. Accreditation assessments help the laboratory staff stay on the cutting edge of technology developments in their field. Dr. Khoury believes this can be achieved in a variety of ways, “including second opinions, subspecialty support, education, and quality improvement.”, Dr. Khoury sees a big-picture outcome for this type of system. The principles of GLP aim to ensure and promote safety, consistency, high quality, and reliability of chemicals in the process of non-clinical and laboratory testing. Quality, safety, and accuracy have long been a priority in the laboratory through regulatory and accreditation measures by organizations such as the CAP and its accreditation and proficiency testing programs. Dr. Khoury, executive director for pathology and laboratory medicine across the Cancer Network, thinks MD Anderson’s record of providing top-quality, leading-edge cancer care and integration of expertise makes it a model to be emulated. The panel considers all comments during finalization of the recommendations. Ibbott This position statement was reviewed and approved by the CAP Executive, September 25, 1996. Manage your lab’s competency assessment Learn More . To access the post-test during the seminar, please bring your own laptop or tablet. The CAP Accreditation Readiness Assessment (CARA) is an optional on-site evaluation and educational program that shows how prepared your laboratory is for the CAP's accreditation process. We assess the quality, quantity, and consistency of the totality of the evidence along with other factors, such as benefits/harms, values, cost, and feedback from the open comment period. What are the CAP Checklists? Rules, ISTA Laboratory Accreditation Standard). www.aabb.org. View 2020 CE programs . This activity is confirmation of your registration into the CAP Reproductive Laboratory Accreditation Program Inspector Training Seminar. CAP Accreditation Programs Laboratory Accreditation: the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors. In this circumstance, they are included in the Laboratory General Checklist used for the central laboratory. Dear Site Principal Investigator and Laboratory Director: All National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS- supported clinical trials involving human subjects must ensure compliance with federal regulations including procedures to protect the safety of all participants. 8 Every number is a life.™. Using its existing infrastructure and electronic health record systems, MD Anderson would potentially be able to become a resource for its network affiliates. The panel also considers professional input not documented in literature (eg, grey literature) based on its scientific merit and expert opinion. By phone:The CAP’s main telephone number is 800-323-4040 or 847-832-7000. Learn more about how pathologists positively impact health care today. “When you have collaborative partnerships with a hub institution that is well known for excellence in a high-stakes discipline such as cancer,” Dr. Khoury says, “that creates a very fertile and dynamic platform for ongoing information exchange and knowledge dissemination fueled by constant interactions across a broad collaborative framework.”. Accreditation is a third-party attestation related to a conformity assessment body (such as certification body, inspection body or laboratory) conveying formal demonstration of its competence to carry out specific conformity assessment tasks (such as certification, inspection and testing).. An authoritative body that performs accreditation is called an 'accreditation body'. principles of the College of American Pathologists (CAP) Laboratory Accreditation Program. Meanwhile, GCLP training materials specifically addressing the conduct of clinical trials in tropical countries also are under development by WHO/TDR and its partners. “Clinical providers, including pathologists, practice as subspecialists at MD Anderson, and this is among the most important elements in making our institution a world leader in cancer,” says Dr. Khoury. ... (CAP's) Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous customized checklist requirements. Addressing various aspects of quality management and containing some of ISO’s best-known standards, there’s the ISO 9000 family. Accreditation vs Certification Certification Accreditation A procedure by which a third party* gives a written assurance that a product, process or service confirms to specific requirements. 5.3 Program Goals: For the graduates to: 5.3. Mayo Clinic Laboratories measures quality not simply by accreditation and licensure, but also by how efficiently esoteric laboratory results are interpreted and applied to a patient’s clinical situation. CAP requirements commonly exceed the standards, bolstering patient care and safety. ISO 15189 Accreditation Program. Scope of accreditation. This position statement was reviewed by the CAP Executive, July 3, 2004 – no changes. For international laboratories and specialty accreditation programs, subsequent inspections are announced. Eng. 37. The third main guiding principle for MD Anderson and its affiliates is quality. Anne Paxton. The goal of the CAP Laboratory Accreditation Program is to improve patient safety by advancing the quality of pathology and laboratory services through education, standard setting, and ensuring laboratories meet or exceed regulatory requirements. The Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002 set out the specifics of pathology accreditation and its requirements. Since their creation, these programs have become widely NABL's scope for accreditation extends to:- September 2016—For the CAP Laboratory Accreditation Program, inspection checklist requirements covering personnel are a perennial concern.They are the leading source of disparities between the findings of the program’s inspectors and inspection audits done by the Centers for Medicare and Medicaid Services. The CAP's peer-based inspector model provides a unique balance of regulatory and educational coaching supported by the most respected worldwide pathology organization. Considering the countless day-to-day interactions—whether it’s between an intake specialist and a nurse or between physicians as they interact over an electronic health record—health care professionals know how essential it is to work with one another to provide the best possible care for their patients. Laboratory Accreditation Program are unannounced. No industry funds are accepted. In a large and complex cancer institution, there is always room for improvement,” he says. THE WORLD ASSOCIATION OF SOCIETIES OF PATHOLOGY AND LABORATORY MEDICINE (WASPaLM) 1. CAP 15189 ecemer 2015 2 Background The ISO 15189:2012 standard includes a clause regarding risk management (4.14.6). •The CAP accredits clinical laboratories that conform to … Disclosure is required throughout the guideline process, shared with all panel members, and cited in the manuscript. Submit a completed Self-Inspection Form in the interim year. Materials are used with the permission of the faculty. As medicine, technology and pathology have evolved since 1946, the CAP has led the way to meet new challenges that result in better patient outcomes. Our guidelines are reviewed every four years or earlier with the publication of substantive and high-quality medical evidence that could potentially alter the original guideline recommendations. Published in the September/October 1996 issue of CAP Newsletter. Metrological traceability 5. Accreditation readiness assessment . 3. The CAP accredits clinical laboratories that conform to the Standards. Transparency 7. We invite review and comment of our draft recommendations during an open comment period. Terms of CAP Accreditation Have a written policy & procedure for investigating complaints. “We look often at our partners to learn and see how they do things; we do also bring valuable knowledge back to our institution; a two-way knowledge exchange process, that is how we think it should be.”. POCT programs may be inspected as sections of the central laboratory if they are registered under the same CLIA-88 number. Dr. Khoury contends that not only does subspecialization improve the quality of patient care, but it also positions pathologists as experts alongside subspecialized oncologists, surgeons, radiation oncologists, and other members of a disease-focused multidisciplinary team. Several important principles are imbedded in the requirements of the standard: 1. The federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal to or more stringent than the U.S. government’s own inspection program. Learn more about CLIA. The accreditation material is developed and maintained by NPAAC. CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis; Meet required standards from CLIA, FDA and OSHA. •The Standards constitute the core principles of the CAP’s Laboratory Accreditation Program •The Standards’ objective is to ensure that accredited clinical laboratories meet the needs of patients, physicians, and other health care practitioners. The LAP, BAP, FDT, and RLAP employ voluntary participation, professional peer review, education, and compliance with established performance standards. Expertise with diversity of laboratories (Not limited to hospital or physician based labs) All Quest Diagnostics' testing locations are appropriately licensed/certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) and as required by certain State laboratory licensure programs. Responsibility 2. LIST OF APPROVED ACCREDITATION ORGANIZATIONS UNDER THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) AABB 4550 Montgomery Ave Suite 700 North Tower Bethesda, MD 20814 . The four laboratory accreditation programs are all created with the primary objective of improving the quality of clinical laboratory services. Our quality and standardization programs exceed the high level of testing proficiency and standardization that auditors require. THE PURPOSES AND NATURE OF LABORATORY ACCREDITATION It is in the interests of patients, of society, ... remains with the medical and scientific professionals engaged in clinical laboratory work. The Checklists undergo regular revision and Checklists may be revised after you receive your packet. Surveys Continuing Education. By mail: Mail accreditation materials to: CAP Accreditation Programs College of American Pathologists 325 Waukegan Road Northfield, IL 60093 By fax: The Accreditation Program’s main fax number is 847 … 2 Introduction . All inspections are performed within the 90-day period preceding the anniversary date. We produce guidelines alone or in conjunction with stakeholder partners. Laboratory Professionals Learning Programs, Archives of Pathology & Laboratory Medicine, Standards for Developing Trustworthy Clinical Practice Guidelines, Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Many of the programs for which we provide certification or verification services require independent accreditation, while others do not. Scientific approach 3. The College of American Pathologists (CAP's) Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous customized checklist requirements. As much as possible and depending on the infrastructure and size of a given hospital, Dr. Khoury and his team work to harness the advantages of subspecialty focus as a means toward achieving the most effective and impactful level of cancer care. We've been in business since 1989, having recognized the need for accreditation bodies to … ENV/MC/CHEM(98)17 2. on-site inspection and comply with the CAP Standards for Laboratory Accreditation. International recognition of the accredited laboratory’s competence, if the accreditation body is a signatory to the mutual recognition arrangement of the International Laboratory Accreditation Cooperation (ILAC). The CAP Program’s interpretation of standards required for recertification or for extenuating circumstances that did not allow the certified individual to earn sufficient points to obtain recertification. In order to address the confusion caused by the perception that accredited laboratories do not operate a recognised quality management system, a joint ISO-ILAC-IAF communique can be provided to laboratory clients to demonstrate that the management system requirements of ISO 15189 meet the principles and requirements of ISO 9001. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. Throughout the accreditation process, we focus on customer needs while ensuring all requirements are met. Pathologists and other laboratory professionals are well aware of the critical role that pathology and the medical laboratory play as a focal point in the health care system to ensure consistently accurate and timely results for patients. Quality, safety, and accuracy have long been a priority in the laboratory through regulatory and accreditation measures by organizations such as the CAP and its accreditation and proficiency testing programs. He says, “Through digital pathology, MD Anderson can provide subspecialty expertise in a timely and almost seamless way for our partner sites, thus allowing our fantastic pathology team in Houston in collaboration with colleagues at affiliate sites to improve the care of millions of patient lives through our network partnership and technology.”, Dr. Khoury predicts, “The potential impact of new technologies like digital pathology and clinical-grade artificial intelligence applications will only continue to grow, especially when laboratory professionals work together and with their hospital leadership to develop collaborative communities of care.”. He sees a lot of potential in digital pathology, which is currently at an inflection point in the United States. Dr. Khoury believes that consistency and a “checklist paradigm” is a highly valuable trait in health care, much like it is an expectation in the aviation industry and other high-stakes fields where errors must be kept to an absolute minimum. The accreditation program shall promote and provide an opportunity for U.S. based entities ... the standards referenced or used by the ABSA Laboratory Accreditation Board in its laboratory accreditation process. Access e-LAB Solutions Suite. CAP Learning × Login. MEDICAL DIRECTOR OF LABORATORIES RESPONSIBILITIES AND ROLE Prepared by: Dr. G. Hoag and Dr. J. Wm. The four laboratory accreditation programs (LAP, BAP, FDT, and RLAP) were all created with the primary objective of improving the quality of clinical laboratory services. Section 4. The CAP provides resources and guidance to laboratories seeking accreditation in programs for biorepositories, genomics, ISO 15189, and more. 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