Suite 1400, wayne, pennsylvania 190871898 usa, 2011. A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within caps molecular pathology checklist mol. The laboratory accreditation program lap was established in 1961. This veterans health administration vha handbook is issued to provide procedures for the administration, accreditation, staffing, and functioning of clinical and anatomic pathology laboratories in department of veterans.
May 01, 20 specimen results that exceed the maximum dilution level for some tests might be appropriately reported as greater than whatever the maximum dilutional level is, if this is acceptable to your laboratory director. Michigan medicine laboratories mlabs offers the uncompromised credibility and integrity at one of the nations top academic medical centers. The accreditation programs guide laboratories to achieve the highest. Accreditation goals and objectives o terms of accreditation o laboratory accreditation manual o standards. The college of american pathologists is the worlds leading organization of boardcertified pathologists. Laboratory accreditation manual pt toolbox standards for laboratory accreditation cap accreditation resources library the following items are available for an additional fee.
Technical requirements within each main clause there are sub clauses 15 in clause 4 and 8 in clause 5 23 in total each sub clause is a packet of information and 37. Immediate notification of cap is required and shall be given for the. Laboratory personnel must receive training regarding the laboratory standard, the chp, and other laboratory safety practices, including exposure detection, physical and health hazards associated with chemicals, and protective measures. College of american pathologists accredited lab baton. Accreditation manual for pathology and clinical laboratory services. Accreditation customers log in to access accreditation resources including manuals, inspection preparation, and templates. Cap accreditation and mohs labs american society for mohs. A2la is the only accreditation organization ao in the world to achieve the centers for medicare and medicaid services cms deemed status and international laboratory accreditation cooperation ilac recognition for iso 15189. The college of american pathologists cap is a memberbased physician organization. Joint commission accreditation is not just for hospitals.
The information below identifies laboratory accreditation resources at the college. As with clinical laboratories, compliance with state and federal requirements for poct are ordinarily met through accreditation by organizations with deemed authority, such as the college of american pathologists cap laboratory accreditation program or the joint commission. The cap provides in its 2011 laboratory general checklist the following definition for autoverification. Many laboratories have applied computer technology to various aspects of laboratory operations. The objective of the standards is to ensure that accredited clinical laboratories meet the needs of. Student testing criteria are consistent and allow for retesting. Laboratories must meet caps accreditation checklists to gain accreditation. The college of american pathologists cap checklists are posted on the cap s web site for information only.
The cap provides a laboratory accreditation program that helps clinical laboratories to meet and exceed cms requirements as well as those of other national and state regulatory bodies. The cap currently inspects and accredits medical laboratories under. The college of american pathologists cap checklists contain the accreditation program requirements, developed using more than 50 years of insight and pathology expertise. Gpc is a major initiative of the center for medical technology policy cap accreditation standards and proficiency testing for diagnostic next generation sequencing. Messner, phd senior vice president center for medical technology policy. Doe consolidated audit program accreditation program doecapap. Customer satisfaction survey with clinical laboratory and. Adherence to the concepts embodied in the well control training. Stepwise laboratory improvement process towards accreditation slipta. For more than 40 years, weve helped health care laboratories transform their practices by meeting and exceeding rigorous performance standards. The checklists align with the clia mandate of high quality laboratory testing by providing a solid foundation for excellence in patient safety, and compliance with policies, procedures, and laboratory processes. The laboratory was advised of this national recognition and congratulated for the excellence of the services being provided.
Commission on laboratory accreditation of the college of. Anthony kurec, ms, hascpdlm, answers questions from two readers. Autoverification is the process by which patient results are generated from interfaced instruments and sent to the laboratory information system, where the results are compared against laboratorydefined acceptance parameters. Following is a list of our certifications and accreditations. An explanation of laboratory governing bodies, regulations. In 2010, vabhs pathology and laboratory service was awarded full twoyear accreditation of all laboratory sites by the college of american pathologists cap. Laboratory services accreditation the joint commission. In 2008 the cap established a voluntary nonregulated accreditation. Quality management college of american pathologists. Laboratory general, all common, anatomic pathology, team leader assessment of director and quality deficiencies timelines preparation for inspection. Joint commission on accreditation of healthcare organizations.
Iso 17025 accreditation requirements for nabl ukas enas. Our dedication to quality is demonstrated through our enrollment in the college of american pathologists cap laboratory accreditation program and our selection of the cap as our accrediting entity. Copies of our most recent accreditation documents can be found below. Laboratory accreditation overview what is laboratory accreditation. The jpc offers pathology consultation, education and research services to federal agencies and operates the national pathology tissue repository in fort dertick forest glen annex, md. Maintain accuracy of test results and ensure accurate patient diagnosis. External quality assurance eqa also known as proficiency testing pt is an interlaboratory peer program that compares a laboratorys test results using unknown. Clinical and laboratory standards institute, 940 west valley road. Food and drug administration fda, provide little guidance, and manufacturers still have to learn what it means to provide instruments to a clinical laboratory. Guide to cap accreditation for international participants. Accreditations and achievements va boston healthcare system.
Accreditation customers log in to access accreditation resources including manuals, inspection preparation, and. College of american pathologists laboratory standards for. Laboratory accreditation is a 3rd party assessment of a calibration or testing laboratory by the laboratory accreditation body, to evaluate the laboratorys compliance to the requirements of isoiec 17025 and any addition applicable accreditation policies. A2la is the only accreditation organization ao in the world to achieve the centers for medicare and medicaid services cms deemed status and international laboratory accreditation cooperation ilac recognition for iso 15189 a2la offers the clinical industry four comprehensive. Read online laboratory accreditation manual webapps. The most current version of the clia regulations part 493, including all changes through 51214. The centers for medicare and medicaid services cms granted the cap laboratory accreditation program deeming authority, which allows cap inspection in lieu of a cms inspection. Cap accreditation and mohs surgery laboratories american society of mohs histotechnology annual meeting, april 30, 2016 kenneth m klein, md, fcap. Good laboratory practices for nonclinical laboratory studies, cfr part 58, subparts af and j 2011 sr 2433, supplemental accreditation requirements. The quality management qm section of the laboratory general checklist contains requirements for the implementation of the qm program and the monitoring of quality.
Reports from 312 laboratories enrolled in the college of american pathologists excel proficiency testing program. All common checklist, cap accreditation program pdf. Laboratory accreditation program college of american. A complaint by a physician concerning a test sent to a referral laboratory is. The joint pathology center jpc is the premier pathology reference center for the federal government.
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. Handbook for accreditation curriculum is consistent among programs and includes exercises and a training manual. The jpc offers pathology consultation, education and research services to federal agencies and operates the national pathology tissue. Understand the iso 17025 standard and how to get accredited. Policy pulmonary function laboratories shall comply with the college of american pathologists cap terms of accreditation to maintain accreditation. Current cap ngs laboratory accreditation requirements 2016. If you need something that you cant find, please contact our client services.
Laboratory accreditation manual college of american. Laboratory safety guidance occupational safety and. Be inspection ready with the 2018 cap accreditation checklists. Linearity from clinical laboratory standards institute clsi document ep6a 2003 o a quantitative analytical method is linear when there exists a mathematically verified straight. This is from cap s laboratory accreditation manual. Cap laboratory accreditation programs professor of pathology and laboratory medicine, rutgers njms and university hospital, newark, nj. The joint pathology center jpc us federal government. Healthcare regulatory information digital pathology association.
March 2018 beginning january 1, 2018, the 8th edition ajcc staging manual should be used for reporting ptnm. Provide a formal system of industry accreditation that recognizes. Copyright 20 np communications, llc no portion of this article can be reproduced without the express written. In july 2011, key stakeholders for slipta were brought together in nairobi, kenya, to reach consensus on the who afro slipta policy guidance and checklist documents. Customer satisfaction with clinical laboratory services is one of the most important quality indicators in laboratory medicine. 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. Jun 11, 2015 the cap laboratory accreditation program is an internationally recognized program and the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors. The cap laboratory accreditation program is an internationally recognized program and the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors.
The joint commission accreditation standards are similar to the clia standards, but the terminology is different. Administrative requirements laboratories must comply with the requirements specified in the terms of accreditation and the cap inspection checklists. All books are in clear copy here, and all files are secure so dont worry about it. Measuring and improving customer satisfaction with clinical laboratory services are essential aspects of laboratory medicine management. Digital pathology is a new technology and industry. Learn about and apply for cap accreditation programs and access tools designed to improve laboratory quality and prepare laboratories for the accreditation process. Laboratory improvement accreditation proficiency testing international laboratories catalog and ordering information. Cliacap standardization from the ground up edrn nih. There are two major agencies that give accreditation to clinical laboratories. Cap laboratory accreditation program protocol required use date. This article is an update of clia88, the joint commission on healthcare organizations jcaho, and the college of american pathologists cap regulatory and accreditation guidelines. Cms has granted the cap laboratory accreditation program deeming authority, which allows cap inspection in lieu of a cms inspection. College of american pathologists laboratory accreditation manual 2012 edition 8 introduction overview of accreditation programs the college of american pathologists cap has established and currently directs multiple accreditation programs. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care.
Official agencies, including the clinical laboratory improvement amendments clia, the college of american pathologists cap, and the u. The quality of the cap checklists is a result of the expertise and collaboration of pathologists and laboratory professionals. Receive cms and internationallyrecognized accreditation for your clinical testing programs. Their standards have been called the toughest and most exacting in the. Cap accreditation readiness assessment cara online competency assessment program qprobes and qtracks. Revised autopsy requirements consistent with vha directive 2011019, the autopsy as a critical component of quality management 4.
Management and technical requirements for iso 17025 nabl ukas jas anz dar dakks enas ias accreditation. Get started on your path to laboratory accreditation. This report describes the important issues considered by the cap committee during the development. The objective of the standards is to ensure that accredited clinical laboratories meet the needs of patients, physicians, and other health care practitioners. Speakers in order of presentation anthonyy,, killeen, md, phd, fcap o chair, instrumentation resource committee william castellani md fcapwilliam castellani, md, fcap o interregional commissioner for the cap laboratory accreditation program and chair of the cap iso15189 committee patricia styer, phd o biostatistics consultant, college of american. Laboratory general checklist college of american pathologists. Laboratory accreditation and the college of american pathologists. Clia regulations and federal register documents refer to the related links outside cms section below for the following information concerning the clinical laboratory improvement amendments clia regulations.
The goal of the cap laboratory accreditation program lap is to improve. A college of american pathologists program of continuous laboratory monitoring and longitudinal performance. Explains the operational activities and responsibilities of anab and its customers excluding forensics and management systems certification bodies. Aug 21, 2014 in this study, we designed a study procedure, defined a study population, and developed a questionnaire for customer satisfaction survey at a tertiary care unit level to evaluate our clinical laboratory and phlebotomy services. Cap accreditation standards and proficiency testing for diagnostic next generation sequencing thursday, march 23, 2017. We help them manage changes in laboratory medicine and technology, as well as the regulatory landscape. Association of medical laboratory immunologists amli may 8, 2020 may 12, 2020. Ma 2100, accreditation manual for laboratory related activities. Accreditation checklists college of american pathologists. Provide a detailed specimen collection procedure to all sites that submit samples to the laboratory. Cap issues laboratory accreditation checklists which support the accreditation process. Agenda clia and accreditation overview cap overview accreditation goals and objectives o terms of accreditation o laboratory accreditation manual o standards o checklists checklists for the mohs surgery laboratory.
Clia regulations and federal register documents cms. A laboratorians view on the college of american pathologists. If in doubt, consult the laboratory manual or call the laboratory. We will share our findings regarding customer satisfaction surveys for clinical laboratory and phlebotomy services. If you are enrolled in the cap s laboratory accreditation program and are. College of american pathologists accredited lab baton rouge. All laboratory systems, including data processing and automation systems, must be validated and tested periodically to provide documented evidence of proper function.
Pathologists cap laboratory accreditation program lap. Validation and optimization of criteria for manual smear. Refer to the related links outside cms section below for the following information concerning the clinical laboratory improvement amendments clia regulations. Autoverification is the process by which patient results are generated from interfaced instruments and sent to the laboratory information system, where the results are compared against laboratory defined acceptance parameters.
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