2014 cap laboratory accreditation manual 2015

One copy of the gen checklist is provided to the inspection team. Cme courses for laboratory directors of moderate complexity laboratories. The college of american pathologists february 2020 release includes 47 revised cancer protocols and one new adult autopsy reporting protocol. In setting evidencebased standards, the guideline provides background and details about the quantitative image analysis qia process and the data and. I was recently in a discussion with someone about iso 17025 calibration requirements. Overview of accreditation programs the college of american pathologists cap directs multiple accreditation programs. Browse the following accreditation programs to learn more about scope, requirements, policies, and other considerations. College of american pathologists laboratory standards for. Laboratory accreditation manual college of american. To address this need, the cap formed an ad hoc committee, the ngs work group, to develop the. 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 exceed regulatory requirements. Laboratories international standards or cap and iso 15189. Accreditation customers log in to access accreditation resources including manuals, inspection preparation, and templates. 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.

Assessment criteria for accreditation of government. There are currently 273 established standards with requirement lists. 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. The biorepositoryspecific checklist contains standards specific for the. Standards document date processed animal manure in organic crop production nop 5006 7222011. Whether youre new to the cap or have been a member for many years, youll find the resources you need to advance your pathology career. Pdf international organization for standardization iso 15189. Cap also offers a service to help laboratories earn accreditation under iso 15189. Following is a list of our certifications and accreditations. The objective of the standards is to ensure that accredited clinical laboratories meet the needs of patients, physicians, and other health care practitioners.

Pathologists laboratory standards for nextgeneration sequencing clinical tests. Assessment criteria for accreditation of government hospitals. Cap lab accreditationchecklistsprotocolsguidelines cap today. Master contains all of the requirements and instr uctions a vailable in pdf, wordxml or excel f ormats. Laboratory accreditation overview what is laboratory accreditation. Purpose of this manual the laboratory accreditation manual is intended to provide laboratories and inspectors a basic overview on the cap s accreditation programs and accreditation processes. Assessment criteria for accreditation of government hospitals laboratories in sudan. 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. Areas in which ngs testing is being accepted for publication june 19, 2014. Review the abft laboratory accreditation manual and program outline carefully, before completing the accreditation application and selfevaluation checklist. Par ticipants of the cap accreditation prog rams ma y do wnload the chec klists from the cap web site. Cap 15189 eceber, 2015 2 backgroundwhy this is necessary the iso 15189. So its no surprise that qc should be subject to quality checks of its own, as one of the pivotal checklist areas that caps laboratory accreditation program focuses on during inspections. A cap sign will be posted in each room patient testing occurs for reporting quality concerns.

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. May 29, 2014 c memorandum of agreement between the department of defense and department of health and human services on the clinical laboratory improvement amendments of 1988 within dod, january 14, 2009 d public law 100578, clinical laboratory improvement amendments of 1988, october 31, 1988. Their standards have been called the toughest and most exacting in the. As at december 2015, hkas has concluded mra with accreditation bodies in 91 85. Pathology residency program manual 2015 2016 a manual for pathology.

Laboratory accreditation manual pt toolbox standards for laboratory accreditation cap accreditation resources library the following items are available for an additional fee. Guidance and instructions for accredited certifying agents and certified operations. From molecular medicine dr aziz, laboratory improvement programs dr zhao and ms palicki, and laboratory accreditation. Cap laboratory accreditation program protocol required use date. We are an independent accreditor whose practical, educational standards have a positive and immediate impact on patient care. It was my understanding that all equipment associated with the tests within our iso 17025 scope needed to have an uncertainty value reported with each calibration. During the third quarter of 2014, subscribers in the voluntary cap qprobes program collected data for this study. Louis meeting aphl, afdo, aafco, usdafsis, and fda initiation of the fdasate laboratory accreditation plan foundation of the iso cap rfa. Gpc is a major initiative of the center for medical technology policy cap accreditation standards and proficiency testing for diagnostic next generation sequencing. The laboratory general gen checklist applies to all sections or departments of the laboratory. Clia laboratory and downstream challenges in computation and interpretation. In this section, you will find the sac publications relating to its programmes, which include the application forms, accreditation criteria documents, technical notes, checklists and other related information. Michigan medicine laboratories mlabs offers the uncompromised credibility and integrity at one of the nations top academic medical centers. Ppt presentation iso 15189 for medical laboratory accreditation.

Accreditation standards laboratory medicine college of physicians. The cap laboratory accreditation program requires institutions to measure customer satisfaction ie, physicians, clients or patients with laboratory services at least once during each 2year inspection cycle gen. Current cap ngs laboratory accreditation requirements 2016. Bacteria microbiology metals biomonitoring wett nutrients. The diagnostic accreditation program of british columbia and the. Cap checklists are living blueprints, used by laboratories and inspectors to ensure quality and patient safety. How is laboratory accreditation aligned to fsma and the integrated foodfeed safety system. New directions in the laboratory accreditation program. 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. Qc acceptance criteria for purposes of laboratory accreditation. They are available in different checklist types and formatting options, including.

Clinical and laboratory standards institute, wayne, pa. We offer both print and electronic versions of our laboratory accreditation standards manual. The college of american pathologists is the worlds leading organization of boardcertified pathologists. Clia regulations and federal register documents cms.

College of american pathologists laboratory standards for next. March 2018 beginning january 1, 2018, the 8th edition ajcc staging manual should be used for reporting ptnm. This site uses cookies and other tracking technologies to assist with navigation, providing feedback, analyzing your use of our products and services, assisting with our promotional and marketing efforts, and provide content from third parties. Cancer protocol templates college of american pathologists. Receive cms and internationallyrecognized accreditation for your clinical testing programs. Copies of our most recent accreditation documents can be found below. Becky damiani, mtascp, senior inspection specialist, laboratory. Measurement uncertainty guide college of american pathologists. Etihad medical centre laboratory joined the network first laboratory out of the mubadala network total 7 laboratories in network. Junior membership free first year fellow free fellow 2018 diplomate of pathology 75% off regular dues. Joint commission accreditation can be earned by many types of health care organizations.

Our standards for laboratory accreditation the joint. 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 annual clinical laboratory management associations clma knowledge lab 2019 will be hosting over 100 different companies from around the u. The cap program is based on rigorous accreditation standards that are translated into detailed checklist requirements cap inspection teams use the checklists, a quality practice blueprint for laboratories, as a guide to assess the laboratorys overall management and operation. 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 cms compliance crosswalk the 2015 edition cms compliance. Implementation of laboratory information system cerner online ordering and. 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. Accreditations and achievements va boston healthcare system. Pathology milestones for anatomic and clinical pathology have been developed. Signatories to the mra recognise the equivalence of one anothers accreditation and accept endorsed test and calibration certificates issuedreports by such laboratories. Cap today will make every effort to answer all relevant questions. Nov 17, 2014 published on nov 17, 2014 management and technical requirements for iso 17025 nabl ukas jas anz dar dakks enas ias accreditation.

Cms compliance crosswalk the cms compliance crosswalk 2015 edition 2015 edition cheryl a. To navigate through the ribbon, use standard browser navigation keys. Renewal company name change application for accreditation of testing laboratory one year two years three years calibration laboratory. To clarify the laboratorys responsibility and the caps 15189 assessment standards, we have developed this interpretive document for the purposes of accreditation. It is important for participants to remember that currently, the cap vpbs survey is an ungraded, educational program. Within the uk there are two laboratory accreditation bodies, operating in complementary fields, the united. Colon protocol has been updated requiring reporting of macroscopic evaluation of mesorectum. Accreditation rule is in the making model laboratory standard. Laboratory general, all common, anatomic pathology, team leader assessment of director and quality deficiencies timelines preparation for inspection. Understand the iso 17025 standard and how to get accredited.

First managed laboratory in nrl network at healthpoint hospital. 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. All inspectors must be familiar with the gen checklist requirements and. Customized to your lab and lab services so probably more like 50 for rlap. However, those questions that are not of general interest may not receive a reply. Title document date introduction 392011 nop organization chart and stakeholder map nop 1001 5 1 3 201 9. Laboratory accreditation program college of american. 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. September 2, 2014 editorially revised may 28, 2015 application for laboratory accreditation. 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. Cap accreditation program college of american pathologists 325 waukegan road northfield, il 600932750.

Laboratory general checklist college of american pathologists. Cap virtual peripheral blood smear vpbs user guide for. Published as an early online release august 25, 2014. Iso 17025 accreditation requirements for nabl ukas enas. An expert laboratory physician or clinical doctoral scientist who. Cap accreditation nrl anatomic pathology laboratory at ccad. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care. Cap laboratory accreditation programs professor of pathology and laboratory medicine, rutgers njms and university hospital, newark, nj. For your question to be considered, you must include your name and address. Physician satisfaction with clinical laboratory services.

The gastrointestinal and breast protocols have been updated to reflect the revised who histologic types. Cap accreditation readiness assessment cara online competency assessment program qprobes and qtracks. Sw846 is not intended to be an analytical training manual. In 2010, vabhs pathology and laboratory service was awarded full twoyear accreditation of all laboratory sites by the college of american pathologists cap.

American association for laboratory accreditation guidestar. Fsma section 202 iso cap 5yrs grant, awarded 31 state laboratories. College of american pathologists accredited lab baton. Laboratory services 2020 national patient safety goals. A2la accreditation programs fulfill regulatory requirements and demonstrate competence and integrity to stakeholders. Hepola, rn, bsn, mba stay up to date with the latest requirements from cms and the joint commission by ordering the latest edition of hcpros renowned and respected accreditation crosswalk.

Learn about and apply for cap accreditation programs and access tools designed to improve laboratory quality and prepare laboratories for the accreditation process. Body fluid testing in the clinical laboratory academy of clinical laboratory physicians and scientists aclps jonathan genzen, md, phd university of utah arup laboratories richard torres, md yale university va connecticut healthcare. Importance of iso 15189 accreditation accreditation to iso 15189 places five additional critical criteria on medical laboratories which include. Additionally, the overall process of accreditation by cap will not be. Cap accreditation and mohs surgery laboratories american society of mohs histotechnology annual meeting, april 30, 2016 kenneth m klein, md, fcap. Published on nov 17, 2014 management and technical requirements for iso 17025 nabl ukas jas anz dar dakks enas ias accreditation. All common checklist college of american pathologists. By 2015, about 60 countries had made iso 15189 part of. The cap program is based on rigorous accreditation standards that are translated into detailed checklist requirements cap inspection teams use the checklists, a quality practice blueprint for laboratories, as a guide to assess the laboratorys overall management and operation the cap releases a new edition annually. Isoiec 17025 accreditation a key building block of the.

May 2015 quality control is second nature and part of the air that laboratories breathe. All participating laboratories completed a general questionnaire outlining laboratory characteristics, demographic data, and scope of service. Accreditation american association for laboratory accreditation. Cap forensic drug laboratory accreditation 20162018.

Cap accreditation standards and proficiency testing for diagnostic next generation sequencing thursday, march 23, 2017. At this time 53 biorepositories are fully cap bap accredited and are in the. The college of american pathologists biorepository accreditation. Accreditation checklists college of american pathologists. A self evaluation verification form will be submitted to cap denoting completion. Our standards for laboratory accreditation the joint commission. A cap selfevaluation will be performed in the interim year of accreditation, with any noted deficiencies corrected. The college of american pathologists cap is a memberbased physician organization. College of american pathologists accredited lab baton rouge.