Licenses and Accreditation CLIA Compliance and CAP Proficiency Testing. The objective of the Standards is to ensure that accredited clinical laboratories meet the needs of patients, physicians, and other health care practitioners. 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'. Scope of accreditation. We uphold guideline integrity by avoiding or actively managing conflict of interest, real or perceived, which could influence or be perceived as influencing guideline decisions. Laboratory professionals access point to a variety of learning opportunities created to support your needs. 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 College of American Pathologists Pathology and Laboratory Quality Center (CAP Center) develops evidence-based guidelines by following the Institute of Medicine's Standards for Developing Trustworthy Clinical Practice Guidelinesto ensure a transparent and unbiased approach. 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. For international laboratories and specialty accreditation programs, subsequent inspections are announced. 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’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 … 5.3 Program Goals: For the graduates to: 5.3. We compose multidisciplinary panels to include a methodologist, major stakeholder representation, and as appropriate, patient advocates. www.aabb.org. 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. Surveys Continuing Education. Accreditation readiness assessment . 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. IMPORTANT: To claim credit and fulfill the inspection team leader training requirement, you must pass the post-test. In 2019, 8th National Conclave for Laboratories was conducted in Chennai. Learn more about how pathologists positively impact health care today. 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. Competency Assessment Program. Transforming world society and the world’s economy to a sustainable basis is the most significant challenge of our time. 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. •The CAP accredits clinical laboratories that conform to … … In this circumstance, they are included in the Laboratory General Checklist used for the central laboratory. Beginning in 2019, we adopted the use of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). 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. 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. The distribution concept outlines the addressees/recipients for controlled or uncontrolled copies of the document. Laboratory Quality Management System 5 Foreword Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. The accreditation material is developed and maintained by NPAAC. 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. The second semester of the fourth year level is the internship program of six (6) months in an accredited training laboratory with Scientific Approach.A laboratory should carry out its work based on acce… The mission statement of the CAP Laboratory Accreditation Program is: “The CAP Laboratory Accreditation Program improves patient safety by advancing the quality of pathology and laboratory services through education and standard setting, and They span three hospitals (Duke University, Duke Regional and Duke Raleigh Hospitals) and include over 40 different specialized work centers, a large point of care testing program and phlebotomy across all of Duke Health. The four laboratory accreditation programs are all created with the primary objective of improving the quality of clinical laboratory services. CMS inspection of waived testing. Program Description Bachelor of Science in Medical Technology/Bachelor in Medical Laboratory Science is a four year program consisting of general education subjects and professional subjects. Around 250 laboratory personnel most of them working as quality managers attended the program. POCT programs may be inspected as sections of the central laboratory if they are registered under the same CLIA-88 number. ENV/MC/CHEM(98)17 3 … CAP Accreditation Programs Laboratory Accreditation: the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors. The goal of the CAP Laboratory Accreditation Program (LAP) 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. 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. ISO 15189 Accreditation Program. 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. 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. 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 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. Dr. Khoury says, “We have a set of diagnostic approaches, biomarker assessments, and other laboratory tools that help streamline the process and, as much as possible, help avoid the possibility of leaving a stone unturned for each and every patient who seeks care at our institution. Ibbott This position statement was reviewed and approved by the CAP Executive, September 25, 1996. 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. While MD Anderson collaborates with laboratories at other hospitals to identify gaps and focus on specialization, consistency, and quality, Dr. Khoury says he is constantly looking beyond the horizon for ways in which collaboration across the Cancer Network can be augmented further. 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. the Laboratory Accreditation Program (LAP) run by CAP. •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 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. We do our best to export our processes in a smart and measured way to our network affiliates depending on their local needs and scope of services.”. 37. 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 is aware of the knowledge and experience of partner member physicians. Built into each of these processes are quality elements and metrics. Scientific approach 3. ENV/MC/CHEM(98)17 2. We strive to balance the panel with knowledgeable subject matter members while ensuring that majority of the panel is free from conflicts of interest. We ensure guideline integrity via a systematic review of the published medical literature using guideline development best practices. 3. Metrological traceability 5. Investments in quality are oftentimes difficult to measure in fiscal terms. (6) The CAP's Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous, customized, and objective checklist requirements. Laboratory Professionals Learning Programs. “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. View 2019 CE programs. Joseph Khoury, MD, FCAP, and his colleagues at MD Anderson Cancer Network practice this type of collaboration and cooperation between their hospital and MD Anderson’s laboratory in Houston and laboratories at different hospitals and health care systems across the United States and the world. The four laboratory accreditation programs are all created with the primary objective of improving the quality of clinical laboratory services. Reproducibility 6. Such relationships allow MD Anderson to expand its impact beyond the institution’s geographic footprint and help disseminate best practices and clinical integration. CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis; Meet required standards from CLIA, FDA and OSHA. Our inspection teams: Are trained, practicing laboratory professionals who understand the workflows and challenges you face because they face them every day as well. Anne Paxton. We invite review and comment of our draft recommendations during an open comment period. The Checklists undergo regular revision and Checklists may be revised after you receive your packet. What are the CAP Checklists? Expertise with diversity of laboratories (Not limited to hospital or physician based labs) Laboratory Professionals Learning Programs, Archives of Pathology & Laboratory Medicine, Standards for Developing Trustworthy Clinical Practice Guidelines, Grading of Recommendations, Assessment, Development and Evaluation (GRADE). 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. “Accordingly, we work closely with our partner members to help them achieve a level of subspecialty focus that works best for their setting. 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 CAP provides resources and guidance to laboratories seeking accreditation in programs for biorepositories, genomics, ISO 15189, and more. Competency Assessment Program . In November 2008, Piedmont Medical Laboratory of Winchester, Virginia became the first laboratory in the United States to … 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. 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. 301-644-3248 Addressing various aspects of quality management and containing some of ISO’s best-known standards, there’s the ISO 9000 family. Learn more about CLIA. Our guidelines clearly articulate recommendations such that users may take appropriate action and implementation can be measured. Eng. 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. 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. principles of the College of American Pathologists (CAP) Laboratory Accreditation Program. 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. Panel members are often leaders within their field and may have associations with industry. The third main guiding principle for MD Anderson and its affiliates is quality. Dr. Khoury is quick to point out that quality should be everyone’s concern. For organizations asking how to improve the quality of their products and services and consistently meet their customers’ expectations, ISO has an answer. Responsibility 2. Skip to Main Content. Several important principles are imbedded in the requirements of the standard: 1. The Clinical Laboratory Program oversees the state licensure of clinical laboratories in Massachusetts and works as the State Agency that administers the Clinical Laboratory Improvement Amendment (CLIA) program on behalf of the Centers for Medicare and Medicaid Services (CMS) for the federal certification of laboratories. The College of American Pathologists (CAP) uses Analytical Measurement Range (AMR) as part of their checklist for their Laboratory Accreditation Program. Access e-LAB Solutions Suite. We produce guidelines alone or in conjunction with stakeholder partners. The CAP's peer-based inspector model provides a unique balance of regulatory and educational coaching supported by the most respected worldwide pathology organization. principle in a new world order, a piecemeal approach—emphasizing some aspects, while neglecting others—is unlikely to yield effective, lasting results. Manage your lab’s competency assessment Learn More . Throughout the accreditation process, we focus on customer needs while ensuring all requirements are met. MD Anderson developed standardized processes that start from patient intake and extend throughout their patient’s journey with cancer and into survivorship. 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. 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 panel also considers professional input not documented in literature (eg, grey literature) based on its scientific merit and expert opinion. 3. Manage rapidly evolving changes in laboratory medicine and technology The history of LAP goes back to 1961, when it was first initiated by CAP and in 1967, the U.S. Clinical Laboratory Improvement Act (CLIA) came into effect, which recognized laboratories accredited by CAP. 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. Effectively participate annually in a CAP- accepted PT program. AMR is used as part of the CAP checklists to satisfy the CLIA ’88 requirements for the term ‘calibration verification’. In addition, Quest Diagnostics' Regional and Esoteric Reference Laboratories are accredited by the … Rules, ISTA Laboratory Accreditation Standard). For 70 years, the CAP has fostered excellence in laboratories and advanced the practice of pathology and laboratory science. 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 - … 2 Introduction . THE WORLD ASSOCIATION OF SOCIETIES OF PATHOLOGY AND LABORATORY MEDICINE (WASPaLM) 1. 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. 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. 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