Discovery of actions by laboratory personnel that violate national state or local regulations. Your laboratorys quality performance depends on the expertise of its employees. Licensureaccreditation michigan medicine laboratories mlabs offers the uncompromised credibility and integrity at one of the nations top academic medical centers. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. Laboratory accreditation manual 2012 edition college of american pathologists maintaining accreditation. The caps peerbased inspector model provides a unique balance of regulatory and educational coaching supported by the most respected. For more information on college of american pathologists cap, please visit college of american pathologists cap. These are common terms in technical manuals and other laboratory publications. System inspection option college of american pathologists. Pereira shows how to interpret the standards requirements. Guide to cap accreditation for international participants. The grossing histotechnologist in surgical pathology. Customer satisfaction survey with clinical laboratory and phlebotomy services at a tertiary care unit level.
The information below identifies laboratory accreditation resources at the college of american pathologists. Regulatory and accreditation requirements college of american pathology general and all common checklists july 2012 gen. All inspectors must be familiar with the gen checklist requirements and. Incorporate your laboratories into a college of american pathologists system inspection, promoting consistently high standards throughout your organization. Laboratory accreditation manual college of american. The center for clinical laboratory medicine cclm issues certificates of accreditation within the dod in lieu of department of health and human services hhs. Laboratories should emphasize these goals in their quality management activities.
Ppt presentation iso 15189 for medical laboratory accreditation. Comprehensive accreditation manual for pathology and clinical laboratory services. College of american pathologists cap iso 15189 view certificate. Clia 88 provides the governmental regulation of laboratories performance. Cap accreditation and mohs surgery laboratories american society of mohs histotechnology annual meeting, april 30, 2016 kenneth m klein, md, fcap. Med 027 is a sadcas accredited medical laboratory provided that all sadcas conditions are complied with this certificate is valid as per the scope stated in the accompanying schedule of accreditation, annexure a, bearing the above accreditation number for medical testing laboratory.
To clarify the laboratorys responsibility and the caps 15189 assessment standards, we have developed this interpretive document for the purposes of accreditation. Joint commission on accreditation of healthcare organizations jcaho. Purpose of this manual the laboratory accreditation manual is intended to provide laboratories and inspectors a basic overview on the caps accreditation programs and accreditation processes. Medical laboratories hong kong accreditation service. Isoiec 17025 general requirements for the competence of testing and calibration laboratories. Pathologists cap laboratory accreditation program lap. 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. How to reduce clerical errors college of american pathologists. Our implementation package allows such laboratories to quickly and easily develop or convert their quality system. Master contains all of the requirements and instr uctions a vailable in pdf, wordxml or excel f ormats. We provide medical laboratories with iso 15189 implementation packages including quality manual, procedures and records to aid in meeting the iso 15189 accreditation requirements. Awarded in 2012, full threeyear accreditation under the medical rehabilitation manual.
The college of american pathologists caps laboratory accreditation program accredits the entire spectrum of laboratory test disciplines with. All quest diagnostics testing locations are appropriately licensedcertified under the clinical laboratory improvement amendments of 1988 clia 88 and as required by certain state laboratory licensure programs. All books are in clear copy here, and all files are secure so dont worry about it. The college of american pathologists is the worlds leading organization of boardcertified pathologists. The laboratory must participate in the next scheduled pt event, if the laboratory accreditation program requires external pt for that analyte. Connect to cap learning tools, assessments, and modules. Accreditation is one way to help ensure your quality standards are maintained and continue to improve.
It also depends on the systems put in place to maintain that quality. Johns hopkins medicine policy number pgen007 pathology point. 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. The cap 15189 accreditation program policies govern the cap 15189 accreditation program cap 15189 program of the college of american pathologists cap. Policy pulmonary function laboratories shall comply with the college of american pathologists cap terms of accreditation to maintain accreditation. Accreditation customers log in to access accreditation resources including manuals, inspection preparation, and templates. This document should be read in conjunction with iso 15189. As part of the 2012 revisions, the ldt validation requirements were. Iso 15189 quality manual, procedures, templates, examples. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care. Immediate notification of cap is required and shall be given for the. Cap must be notified as soon as laboratory finds itself to be subject to validation inspection. Laboratory services accreditation the joint commission. Accreditation manual for pathology and clinical laboratory services.
The caps main telephone number is 8003234040 or 8478327000. It represents the fullyapproved version for use in the lap as of the date given in the header. Cap accreditation programs policy manual version 2017. They are available in different checklist types and formatting options, including. Manage your laboratory s accreditation documents, including customized accreditation checklists and test menuactivity change forms.
To clarify the laboratory s responsibility and the caps 15189 assessment standards, we have developed this interpretive document for the purposes of accreditation. All clia standards are associated with a d or deficiency tag. The college of american pathologists cap checklists contain the accreditation program requirements, developed using more than 50 years of insight and pathology expertise. Customer satisfaction survey with clinical laboratory and. Laboratory accreditation program college of american. Cap accreditation checklists2019 edition the college of american pathologists cap accreditation checklists contain the cap accreditation program requirements, developed on more than 50 years of insight and pathology expertise. Nms labs licensure and accreditation are your assurance that our laboratory has met or exceeded a certifying agencys high standards of excellence.
This manual states the minimal conditions that all. For more than 40 years, weve helped health care laboratories transform their practices by meeting and exceeding rigorous performance standards. The iso 15189 is widely popular for laboratories, but many aspects are confusing, vague, and misunderstood. The biorepositoryspecific checklist contains standards specific for. Current cap ngs laboratory accreditation requirements 2016.
Accreditation checklists college of american pathologists. Get started on your path to laboratory accreditation. College of american pathologists commission on laboratory accreditation. A total of 90 inspections were completed between may 2012 and december 2016.
College of american pathologists accredited lab baton. College of american pathologists accredited lab baton rouge. Finally, interfaces to the laboratory information system should be tested at the new location. Cap 15189 accreditation program policies cap june 201915189 7 4. Clinical and laboratory standards institute, wayne, pa, 2012. Centers for disease control global aids program, 2012. Manage rapidly evolving changes in laboratory medicine and technology. Comparing agencies and considering your needs will. Laboratories receive a cap system inspection certificate to signify successful participation. Cap laboratory accreditation programs professor of pathology and laboratory medicine, rutgers njms and university hospital, newark, nj.
The cap laboratory accreditation program is an internationally. Cap issues laboratory accreditation checklists which support the accreditation. Licenses and accreditation clia compliance and cap proficiency testing. This college of american pathologists cap laboratory accreditation program lap checklist is provided as a microsoft word 2000 electronic file for convenience and for educational purposes.
Cap laboratory accreditation helps laboratories in maintaining the accuracy of test results and ensure accurate patient diagnosis. For the introduction of the iso 15189 standard, you need. Laboratory general, all common, anatomic pathology, team leader assessment of director and quality deficiencies timelines preparation for inspection. Quality manual this document, together with all related procedure manuals, represents the quality management system of the department of pathology, peterborough and stamford hospitals nhs foundation trust. Cap is the main regulatory body that determines accreditation requirements in surgical pathology. 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.
Joint commission accreditation is not just for hospitals. 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. One of the requirements in the clinical laboratory improvement amendments of 1988 clia 88 states the. Feb 17, 2016 requirements for accreditation quality manual. When a laboratory is found in noncompliance with a particular requirement, the surveyor cites the. All common checklist college of american pathologists. Describes laboratory policies, organization structure, job descriptions and personnel interrelations. Access user guides and pt exception investigation checklist tools. Anthony killeen, md, phd director of clinical laboratories.
Clia88 establishes minimum performance standards for all clinical laboratories. As laboratory medicine advances, the cap accreditation checklists guide laboratories to achieve continuous compliance and deliver the highest standard of. One copy of the gen checklist is provided to the inspection team. The quality of the cap checklists is a result of the expertise and collaboration of pathologists and laboratory professionals. Regulatory accreditation programs are continual processes. Accreditations and achievements va boston healthcare system. It has been compiled to meet the requirements of the 2012 revision of iso 15189 medical laboratories requirements for quality and. A summary list of nms labs accreditations and licensure can be found here. Read online laboratory accreditation manual webapps. In 2010, vabhs pathology and laboratory service was awarded full twoyear accreditation of all laboratory sites by the college of american pathologists cap. Learn about and apply for cap accreditation programs and access tools designed to improve laboratory quality and prepare laboratories for the accreditation process. International organization for standardization iso 15189. Hoklas 015 technical criteria for laboratory accreditation. The college of american pathologists biorepository accreditation.
In addition, the cap retains deemed status with the joint commission, united network for organ sharing, the national marrow donor program, the foundation for the accreditation of cellular therapies, and many us state agencies. Getting terminology in line with standards like iso 15189 is a benefit. This is from cap s laboratory accreditation manual. The cap urges pathologists and laboratories to apply for small business loans. Frank schneider, md, fcap chair, cap 15189 committee gene n. Work with the lab to find a mutually agreeable date must be done within three months prior to anniversary work with tracy bousquet at cap if issues arise when scheduling 8003234040 ext. Manage your laboratory s online access, user permissions, and your individual profile.
Maintain accuracy of test results and ensure accurate patient diagnosis. Anthony killeen, md, phd director of clinical laboratories department of laboratory medicine and pathology university of minnesota medical center fairview. The college of american pathologists cap offers a suite of laboratory accreditation pro grams, including one specific to accreditation to the international organization for stan dardization iso 15189 standard for quality management specific to medical laboratories. While a certificate provides effective and expiration dates, laboratories remain accredited while they wait for the receipt of a new certificate, even if the expiration date has passed. Pdf international organization for standardization iso 15189. The laboratory accreditation program lap was established in 1961. Arup laboratories as a nonprofit, academic institution of the university of utah and its department of pathology, arup believes in collaborating, sharing knowledge, and contributing to laboratory science in ways that benefit our clients and their patients. Customized to your lab and lab services so probably more like 50 for rlap. Cap ngs accreditation requirements first published in 2012. Sam clinical laboratory was accredited by the college of american pathologists cap in 2015. Cap requirements commonly exceed the standards, bolstering patient care and safety. Importance of iso 15189 accreditation accreditation to iso 15189 places five additional critical criteria on medical laboratories which include.
Doddoe quality system manual qsm optional requirements for the accreditation of field work a2la also offers additional requirements for laboratories performing tests in the field i. The laboratory general gen checklist applies to all sections or departments of the laboratory. The need to gain iso 15189 compliance and accreditation impacts many medical and clinical laboratories. New processes and selfchecks can reduce these nonpatientrelated clerical errors. Cap accreditation program college of american pathologists 325 waukegan road northfield, il 600932750. Satisfy every clause mentioned in the standard iso 15189. Cap laboratory accreditation program hematology checklist question hem. 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 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. Blood gas laboratory compliance with cap terms of accreditation. In total, clia covers approximately 260,000 laboratory entities. The college of american pathologists caps laboratory accreditation program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous customized checklist requirements. Following is a list of our certifications and accreditations. Additionally, the overall process of accreditation by cap will not be. Cap accreditation standards and proficiency testing for diagnostic next generation sequencing thursday, march 23, 2017. National committee for clinical laboratory standards former name of clsi. The college of american pathologists cap is a clia accredited organization composed of boardcertified pathologists with a mission to serve patients, pathologists, and the public through the advocation of excellence in pathology and laboratory medicine worldwide. Mission of the cap laboratory accreditation program improve patient safety by advancing the quality of pathology and laboratory services through education and standard setting, and ensuring laboratories meet or exceed regulatory requirements purpose of inspection is to o improve quality of lab services for the benefit of the patient. The systems inspection option follows the same twoyear cycle, peerbased inspection model, and checklist requirements as the laboratory accreditation program. All medical laboratories as defined in the glossary.
Commission on laboratory accreditation of the college of. This checklist is used in conjunction with the all common and laboratory general checklists to inspect a. Other accreditation agencies, such as the joint commission, are neutral to grossing compliance issues. Measurement uncertainty guide college of american pathologists. Please contact the appropriate person by phone, mail, or fax. Information specific to international laboratories interested in cap accreditation is available in the international laboratories section. September 2019 hoklas 015 fifth edition abridged version requirements and notes of iso. Cap also offers a service to help laboratories earn accreditation under.
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 laboratory was advised of this national recognition and congratulated for the excellence of the services being provided. Preparing for the inspection schedule the inspection as soon as possible after receiving notice. The college of american pathologists laboratory accreditation program caplap mainly inspects large laboratories directed by pathologists.
Par ticipants of the cap accreditation prog rams ma y do wnload the chec klists from the cap web site. This accreditation demonstrates to the marketplace and to regulators that the medical laboratories have met the ias accreditation requirements and are periodically monitored for compliance. Providing advice on the type of sample, and testing that may be required interacting with clinical staff by placing a responsibility on the laboratory to liaise with clinician who refer patient samples. Jcaho and cap are professional organizations which have received deemed. Clinical laboratory improvement amendments clia cms. Doe consolidated audit program doe cap accreditation. Overview of accreditation programs the college of american pathologists cap directs multiple accreditation. The cap accredits clinical laboratories that conform to the standards. Cap ranks aculabs as deficiencyfree in 2019 inspection aculabs. This manual states the minimal conditions that all laboratories must meet to be certified to perform testing on human specimens. See the biohazard warning at the end of these instructions. 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. Cap 15189 eceber, 2015 2 backgroundwhy this is necessary the iso 15189. 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.
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