Customer satisfaction survey with clinical laboratory and. Pdf quality and the college of american pathologists. Quality management college of american pathologists. Quantitative image analysis of her2 immunohistochemistry. For more than 40 years, weve helped health care laboratories transform their practices by meeting and exceeding rigorous performance standards. Laboratory safety guidance occupational safety and. 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. Immediate notification of cap is required and shall be given for the. 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 s laboratory accreditation program is unlike any other.
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. The college of american pathologists cap checklists are posted on the cap s web site for information only. Food and drug administration fda, provide little guidance, and manufacturers still have to learn what it means to provide instruments to a clinical laboratory. Your laboratory 3 cap order processing septemberdecember. Laboratory standard operating procedures manual selection and evaluation of reference labs effective date. Cap laboratory accreditation programs professor of pathology and laboratory medicine, rutgers njms and university hospital, newark, nj. The guideline refers readers to the college of american pathologists laboratory accreditation program and the principles of analytic validation of. February 2020regular readers of cap today know i believe that it is extremely important for cap members to become politically active. The selection of the reference laboratories for this institution has been based on the quality and reliability. There are two major agencies that give accreditation to clinical laboratories, namely, the joint commission on. College of american pathologists accredited lab baton.
If playback doesnt begin shortly, try restarting your device. Cap laboratory accreditation program is an international program designed to improve patient safety by advancing the quality of pathology and laboratory services through education, standard setting, and ensuring laboratories meet or exceed. Your path to laboratory excellencecollege of american pathologists accreditation programs youtube. Protocol for the examination of radical prostatectomy. Its an engaging, dynamic, collaborative experience that fosters continuous improvement. Joint commission accreditation is not just for hospitals. Fa 2004, application for isoiec 17025 accreditation for testing, calibration, and dimensional measurement labs. Grow personally and professionally at the 2020 pathologists leadership summit. Are the various distributed models described and other variations perhaps not described still considered compliant with clia from caps perspective. Nfrc documents any revisions or additions to the nfrc product certification program documents, both technical and program, which have been implemented andor approved by nfrc board of directors take precedence over this manual. Laboratory accreditation overview what is laboratory accreditation. The college of american pathologists cap checklists contain the accreditation program requirements, developed using more than 50 years of insight and pathology expertise. Cancer protocol templates college of american pathologists.
The college of american pathologists february 2020 release includes 47 revised cancer protocols and one new adult autopsy reporting protocol. Manual daids guidelines for good clinical laboratory practice standards. If you havent registered already, i encourage you to consider. The information below identifies laboratory accreditation resources at the college of american pathologists. Cap accreditation standards and proficiency testing for diagnostic next generation sequencing thursday, march 23, 2017.
Learn the importance of pathologists telling their story to their legislators to help make a difference for pathology and make patient care better at the 2020 pathologists leadership summit. 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. In july 2011, key stakeholders for slipta were brought together in nairobi, kenya, to. Managing the pre and postanalytical phases of the total. College of american pathologists cap retention of laboratory records and materials the college of american pathologists makes the following recommendations for the minimum requirements for the retention of laboratory records and materials.
Cap college of american pathologists cdc centers for disease control and prevention. The cap s main telephone number is 8003234040 or 8478327000. Gpc is a major initiative of the center for medical technology policy cap accreditation standards and proficiency testing for diagnostic next generation sequencing. A college of american pathologists program of continuous laboratory. Colon protocol has been updated requiring reporting of macroscopic evaluation of mesorectum. Your path to laboratory excellencecollege of american pathologists. Overview even during these times when resources in the laboratory can be a limiting factor, it is possible to maintain readiness for a regulatory inspection every day. November 2019 includes ptnm requirements from the 8th edition, ajcc staging manual for accreditation purposes, this protocol should be used for the following procedures and tumor types. Commission on laboratory accreditation of the college of. The laboratory was advised of this national recognition and congratulated for the excellence of the services being provided. Certification and inspection agency operations manual page 2 2.
Student testing criteria are consistent and allow for retesting. Customer satisfaction with clinical laboratory services is one of the most important quality indicators in laboratory medicine. If you are enrolled in the cap s laboratory accreditation program and are. Quality system program manual laboratory testing inc. College of american pathologists accredited lab baton rouge. This manual explains procedures for implementing the washington state environmental laboratory accreditation program, administered by the washington state department of ecology.
The joint commission accreditation standards are similar to the clia standards, but the terminology is different. 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. Receive cms and internationallyrecognized accreditation for your clinical testing programs. Laboratory quality management system 19 issn 20540930 print, issn 20540949 online for a medical testing and diagnostic laboratory. H department of medical laboratory science, faculty of allied health sciences, bayero. Accreditation checklists college of american pathologists. Accreditation customers log in to access accreditation resources including manuals, inspection preparation, and templates.
Laboratory quality regulations and accreditation standards in. Stepwise laboratory improvement process towards accreditation slipta. The caep accreditation manual and supplementary guides and information provide key players in the accreditation of educator preparation programs a onestop source of information about what these providers must do to earn caep accreditation. Please contact the appropriate person by phone, mail, or fax. Adherence to the concepts embodied in the well control training. Daids guidelines for good clinical laboratory practice. Comprehensive pointofcare testing information about regulatory, testing, products, events, articles, and more. Provide a formal system of industry accreditation that recognizes. Learn about and apply for cap accreditation programs and access tools designed to improve laboratory quality and prepare laboratories for the accreditation process. Jun 11, 2015 college of american pathologists accredited lab 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. Linearity from clinical laboratory standards institute clsi document ep6a 2003 o a quantitative analytical method is linear when there exists a mathematically verified straight. The laboratory accreditation program lap was established in 1961. Measuring and improving customer satisfaction with clinical laboratory services are essential aspects of laboratory medicine management. The college of american pathologists cap is dedicated to pathology and laboratory medicine quality.
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. The clinical laboratory improvement amendments of 1988 clia and implementing regulations at 42 cfr 493. The who afro stepwise laboratory accreditation preparedness scheme was launched in kigali in. Aslm african society for laboratory medicine cap college of american pathologists cdc centers for disease control and prevention united states.
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. Digital pathology is a new technology and industry. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care. This manual will be revised from time to time as needed. Laboratory accreditation and the college of american pathologists 2 things to know for cap laboratory accreditation 5 application process 7 director responsibilities 8 document control system 11 chemical hygiene plan 12. Validation and optimization of criteria for manual smear.
Quality system program manual revision 21 dated 5119 see section 20 for procedure number and title page 2 of 41 section i policy and authority statement it is the policy of laboratory testing, incorporated lti, as a material organization, to furnish and perform testing services in nondestructive, mechanical, chemical, metallographic and metrology fields. Cap accreditation and mohs surgery laboratories american society of mohs histotechnology annual meeting, april 30, 2016 kenneth m klein, md, fcap. 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. Procedure description prostatectomy includes specimens designated radical prostatectomy. Laboratory services accreditation the joint commission. The quality of the cap checklists is a result of the expertise and collaboration of pathologists and laboratory professionals. The upcoming pathologists leadership summit, which will take place may 25 in washington, dc, will give you the opportunity to do so. Official agencies, including the clinical laboratory improvement amendments clia, the college of american pathologists cap, and the u. The cap s laboratory accreditation program, proficiency testing program, qprobes and qtracks. Policy pulmonary function laboratories shall comply with the college of american pathologists cap terms of accreditation to maintain accreditation.
Be inspection ready with the 2018 cap accreditation checklists. The quality system program manual may also be issued to other authorized stakeholders upon request. Laboratory accreditation program college of american. The manual provides guidance to laboratories participating in the program. In 2009, the who regional committee launched the stepwise laboratory accreditation preparedness scheme in kigali. Get started on your path to laboratory accreditation. Laboratory quality management system 7 foreword achieving, maintaining and improving accuracy, timeliness and reliability are major. Cap laboratory accreditation program protocol required use date. International standards for cellular therapy product collection, processing, and administration accreditation manual guidance to accompany the factjacie international standards for cellular therapy product collection, processing, and administration, fourth edition draft fifth edition march 2011 notice. Is qia really superior to manual interpretation for her2 immunohistochemistry for breast.
Laboratory general, all common, anatomic pathology, team leader assessment of director and quality deficiencies timelines preparation for inspection. Who guide for the stepwise laboratory improvement process. Copies of our most recent accreditation documents can be found below. This document is designed for a broad range of usersincluding faculty and administrators from educator. 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. The quality management qm section of the laboratory general checklist contains requirements for the implementation of the qm program and the monitoring of quality. A college of american pathologists program of continuous laboratory monitoring. Current cap ngs laboratory accreditation requirements 2016. We help them manage changes in laboratory medicine and technology, as well as the regulatory landscape. The gastrointestinal and breast protocols have been updated to reflect the revised who histologic types. To address this need, the cap formed an ad hoc committee, the ngs work group, to develop the. Recommendations may be incorporated into future versions of the cap laboratory accreditation program.
The keys to readiness that we will address today are. In addition to information on osha standards and guidance that deal with laboratory hazards, appendices are provided with information on other governmental and nongovernmental agencies that deal with various aspects of laboratory safety. The objective of the standards is to ensure that accredited biorepository. Managing the pre and postanalytical phases of the total testing process. Explains the operational activities and responsibilities of anab and its customers excluding forensics and management systems certification bodies. College of american pathologists laboratory standards for.
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