This report describes the important issues considered by the cap committee during the development. The laboratory was advised of this national recognition and congratulated for the excellence of the services being provided. Customer satisfaction survey with clinical laboratory and. 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. Doe consolidated audit program accreditation program doecapap. 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. Pathologists cap laboratory accreditation program lap.
Cap accreditation and mohs surgery laboratories american society of mohs histotechnology annual meeting, april 30, 2016 kenneth m klein, md, fcap. Joint commission accreditation is not just for hospitals. 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. Laboratory improvement accreditation proficiency testing international laboratories catalog and ordering information. Cap laboratory accreditation programs professor of pathology and laboratory medicine, rutgers njms and university hospital, newark, nj. If in doubt, consult the laboratory manual or call the laboratory. All laboratory systems, including data processing and automation systems, must be validated and tested periodically to provide documented evidence of proper function. Food and drug administration fda, provide little guidance, and manufacturers still have to learn what it means to provide instruments to a clinical laboratory. 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. Laboratory accreditation manual pt toolbox standards for laboratory accreditation cap accreditation resources library the following items are available for an additional fee. There are two major agencies that give accreditation to clinical laboratories. Adherence to the concepts embodied in the well control training.
In 2008 the cap established a voluntary nonregulated accreditation. Guide to cap accreditation for international participants. Cap accreditation and mohs labs american society for mohs. College of american pathologists laboratory standards for. Joint commission on accreditation of healthcare organizations. Cliacap standardization from the ground up edrn nih. Anthony is clinical associate professor, emeritus, at suny upstate medical university in syracuse, ny.
The college of american pathologists cap checklists are posted on the cap s web site for information only. Laboratory general, all common, anatomic pathology, team leader assessment of director and quality deficiencies timelines preparation for inspection. Association of medical laboratory immunologists amli may 8, 2020 may 12, 2020. Laboratory accreditation and the college of american pathologists. The most current version of the clia regulations part 493, including all changes through 51214. Healthcare regulatory information digital pathology association. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care. Clia regulations and federal register documents cms. Immediate notification of cap is required and shall be given for the. In 2010, vabhs pathology and laboratory service was awarded full twoyear accreditation of all laboratory sites by the college of american pathologists cap. Quality management college of american pathologists. Be inspection ready with the 2018 cap accreditation checklists. Get started on your path to laboratory accreditation. Gpc is a major initiative of the center for medical technology policy cap accreditation standards and proficiency testing for diagnostic next generation sequencing.
Receive cms and internationallyrecognized accreditation for your clinical testing programs. Cap laboratory accreditation program protocol required use date. If you are enrolled in the cap s laboratory accreditation program and are. Anthony kurec, ms, hascpdlm, answers questions from two readers. Learn about and apply for cap accreditation programs and access tools designed to improve laboratory quality and prepare laboratories for the accreditation process.
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. Provide a detailed specimen collection procedure to all sites that submit samples to the laboratory. Refer to the related links outside cms section below for the following information concerning the clinical laboratory improvement amendments clia regulations. Handbook for accreditation curriculum is consistent among programs and includes exercises and a training manual. Revised autopsy requirements consistent with vha directive 2011019, the autopsy as a critical component of quality management 4. Ma 2100, accreditation manual for laboratory related activities. Measuring and improving customer satisfaction with clinical laboratory services are essential aspects of laboratory medicine management. Accreditation checklists college of american pathologists. 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. Accreditations and achievements va boston healthcare system. Stepwise laboratory improvement process towards accreditation slipta. Copies of our most recent accreditation documents can be found below. The quality of the cap checklists is a result of the expertise and collaboration of pathologists and laboratory professionals.
Laboratory accreditation program college of american. 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. 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. All common checklist, cap accreditation program pdf.
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. Accreditation customers log in to access accreditation resources including manuals, inspection preparation, and templates. Laboratories must meet caps accreditation checklists to gain accreditation. Laboratory safety guidance occupational safety and.
The cap provides in its 2011 laboratory general checklist the following definition for autoverification. Student testing criteria are consistent and allow for retesting. Cap accreditation readiness assessment cara online competency assessment program qprobes and qtracks. Provide a formal system of industry accreditation that recognizes. Cap issues laboratory accreditation checklists which support the accreditation process. 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. College of american pathologists accredited lab baton. Good laboratory practices for nonclinical laboratory studies, cfr part 58, subparts af and j 2011 sr 2433, supplemental accreditation requirements. Michigan medicine laboratories mlabs offers the uncompromised credibility and integrity at one of the nations top academic medical centers. Laboratory general checklist college of american pathologists. The college of american pathologists cap is a memberbased physician organization. The laboratory accreditation program lap was established in 1961. 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. Following is a list of our certifications and accreditations.
The accreditation programs guide laboratories to achieve the highest. Maintain accuracy of test results and ensure accurate patient diagnosis. Customer satisfaction with clinical laboratory services is one of the most important quality indicators in laboratory medicine. 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. The goal of the cap laboratory accreditation program lap is to improve. Clinical and laboratory standards institute, 940 west valley road. Accreditation goals and objectives o terms of accreditation o laboratory accreditation manual o standards. Digital pathology is a new technology and industry. If you need something that you cant find, please contact our client services. College of american pathologists accredited lab baton rouge.
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. Current cap ngs laboratory accreditation requirements 2016. Cap accreditation standards and proficiency testing for diagnostic next generation sequencing thursday, march 23, 2017. Administrative requirements laboratories must comply with the requirements specified in the terms of accreditation and the cap inspection checklists. Suite 1400, wayne, pennsylvania 190871898 usa, 2011. The jpc offers pathology consultation, education and research services to federal agencies and operates the national pathology tissue. 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. The college of american pathologists is the worlds leading organization of boardcertified pathologists. External quality assurance eqa also known as proficiency testing pt is an interlaboratory peer program that compares a laboratorys test results using unknown. 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. 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. 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. Linearity from clinical laboratory standards institute clsi document ep6a 2003 o a quantitative analytical method is linear when there exists a mathematically verified straight. 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.
Copyright 20 np communications, llc no portion of this article can be reproduced without the express written. 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. Read online laboratory accreditation manual webapps. A college of american pathologists program of continuous laboratory monitoring and longitudinal performance. The information below identifies laboratory accreditation resources at the college. 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. Many laboratories have applied computer technology to various aspects of laboratory operations. Validation and optimization of criteria for manual smear. Laboratory services accreditation the joint commission. 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. Management and technical requirements for iso 17025 nabl ukas jas anz dar dakks enas ias accreditation.
All books are in clear copy here, and all files are secure so dont worry about it. We help them manage changes in laboratory medicine and technology, as well as the regulatory landscape. Policy pulmonary function laboratories shall comply with the college of american pathologists cap terms of accreditation to maintain accreditation. A laboratorians view on the college of american pathologists. Commission on laboratory accreditation of the college of. The college of american pathologists cap checklists contain the accreditation program requirements, developed using more than 50 years of insight and pathology expertise.
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. 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. The joint pathology center jpc is the premier pathology reference center for the federal government. A complaint by a physician concerning a test sent to a referral laboratory is. Iso 17025 accreditation requirements for nabl ukas enas. Explains the operational activities and responsibilities of anab and its customers excluding forensics and management systems certification bodies. 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.
For more than 40 years, weve helped health care laboratories transform their practices by meeting and exceeding rigorous performance standards. 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. The joint pathology center jpc us federal government. Laboratory accreditation overview what is laboratory accreditation. Reports from 312 laboratories enrolled in the college of american pathologists excel proficiency testing program. Cms has granted the cap laboratory accreditation program deeming authority, which allows cap inspection in lieu of a cms inspection.
The quality management qm section of the laboratory general checklist contains requirements for the implementation of the qm program and the monitoring of quality. March 2018 beginning january 1, 2018, the 8th edition ajcc staging manual should be used for reporting ptnm. 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. Understand the iso 17025 standard and how to get accredited. The joint commission accreditation standards are similar to the clia standards, but the terminology is different. 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 objective of the standards is to ensure that accredited clinical laboratories meet the needs of patients, physicians, and other health care practitioners. Messner, phd senior vice president center for medical technology policy. The cap currently inspects and accredits medical laboratories under. Official agencies, including the clinical laboratory improvement amendments clia, the college of american pathologists cap, and the u. This is from cap s laboratory accreditation manual.