2014 cap laboratory accreditation manual 2015 pdf

All common checklist college of american pathologists. 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. Program outline, the laboratory accreditation manual, an application form and a checklist to be completed by the laboratory director and sent back with the application. Tools to improve the quality of genetic testing services article pdf available in zdravniski vestnik 794. Joint commission standards help you develop strategies to address the. Policy 0110 compliance with cap terms effective date. Two female laboratory technicians examing a blood sample. Areas in which ngs testing is being accepted for publication june 19, 2014.

Handbook for accreditation curriculum is consistent among programs and includes exercises and a training manual. 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. Published on nov 17, 2014 management and technical requirements for iso 17025 nabl ukas jas anz dar dakks enas ias accreditation. College of american pathologists accredited lab baton rouge. Adopt a new laboratory accreditation standard we agree. Jan 01, 2015 accreditation manual for laboratory related programs published on jan 1, 2015 this manual explains the operational activities and responsibilities of the ansiasq national accreditation board. A2las chemical testing field covers a broad array of techniques and analytes in many different industries. Laboratory accreditation and participation in external quality assessment schemes. Pdf international organization for standardization iso 15189.

Jan 17, 2012 this video by the college of american pathologists provides an overview of the content of the cap qmed quality manual development course, which explains how to create a processbased quality. Assessment criteria for accreditation of government. Cap accreditation program college of american pathologists 325 waukegan road northfield, il 600932750. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care. Cap virtual peripheral blood smear vpbs user guide for. Clinical and laboratory standards institute, wayne, pa.

The gastrointestinal and breast protocols have been updated to reflect the revised who histologic types. Accreditation manual for laboratory related programs published on jan 1, 2015 this manual explains the operational activities and responsibilities of. A list of laboratories that have been convicted, under federal or state laws relating to fraud and abuse, false billing, or kickbacks. Cap accreditation and mohs surgery laboratories american society of mohs histotechnology annual meeting, april 30, 2016 kenneth m klein, md, fcap. Laboratory general checklist college of american pathologists. Understand the iso 17025 standard and how to get accredited.

Practical guide to specimen handling in surgical pathology. This report should be communicated with appropriate survey and. The material is available in one or more electronic formats on the abft website. Cancer protocol templates college of american pathologists. Terms like procedure, policy, document, preventive action, and corrective action are used by the clinical and laboratory standards institute. 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. We are an independent accreditor whose practical, educational standards have a positive and immediate impact on patient care. Assessment criteria for accreditation of government hospitals. The history of lap goes back to 1961, when it was first initiated by cap and in 1967, the u. A patient safety event that did not reach the patient. Clinical laboratory improvement act of 1967 pdf icon external icon 81 stat.

While this international standard is intended to use throughout recognized disciplines of medical laboratory services. College of american pathologists laboratory standards for next. The objective of the standards is to ensure that accredited clinical laboratories meet the needs of patients, physicians, and other health care practitioners. Pathology residency program manual 20152016 a manual for pathology. Iso 17025 accreditation requirements for nabl ukas enas. Most common deficiencies caps 2014 top ten checklist number description percent cited gen. A twopart standard iso 15189 international standard, based upon iso 17025 and iso 9001, provides requirements for competence and quality that are particular to medical laboratories. Detailed requirements for accreditation by the college of american pathologists article pdf available in molecular biology today 23. Adherence to the concepts embodied in the well control training. Clinical laboratory improvement act clia came into effect. Updated to reflect lap committee 2015 checklist changes 6. To clarify the laboratorys responsibility and the caps 15189 assessment standards, we have developed this interpretive document for the purposes of accreditation. 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 accreditation.

University of texas medical branch pulmonary function clinic. Cap lab accreditationchecklistsprotocolsguidelines cap today. 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 laboratory and downstream challenges in computation and interpretation. By 2015, about 60 countries had made iso 15189 part of. Cap laboratory accreditation program, all common checklist. Cap lab accreditationchecklistsprotocolsguidelines. Laboratory accreditation manual cap suny downstate. Pathology milestones for anatomic and clinical pathology have been developed. Student testing criteria are consistent and allow for retesting. The biorepositoryspecific checklist contains standards specific for the protection of. Provide a formal system of industry accreditation that recognizes. The clinical laboratory improvement amendments of 1988 clia and implementing regulations at 42 cfr 493.

Joint commission standards help you develop strategies to address the most complex issues and identified. Laboratory general, all common, anatomic pathology, team leader assessment of director and quality deficiencies timelines preparation for inspection. From molecular medicine dr aziz, laboratory improvement programs dr zhao and ms palicki, and laboratory accreditation. Measurement uncertainty guide college of american pathologists. A patientsafety event that reaches the but does not cause harm. Cap also offers a service to help laboratories earn accreditation under iso.

College of american pathologists laboratory standards for. Cap accreditation and checklists update lyn wielgos, mtascp november 3, 2017 checklist editor, cap accreditation programs. The keys to readiness that we will address today are. This video by the college of american pathologists provides an overview of the content of the cap qmed quality manual development course, which explains how to create a. Iso 15189 medical laboratory accreditation pdf flipbook. 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.

September 2019four new checklist requirements for waived molecularbased microbiology tests have been added to the cap pointofcare testing, limited service laboratory, and immunology accreditation program checklists, as part of the 2019 checklist edition released this month. Accreditation manual for laboratory related programs by anab. 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. Laboratory accreditation standards webinar may 5, 2016 may 5, 2016. Companies are required to comply with current editions of all sac publications relevant to their accreditation or application. 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. 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.

Once approval has been granted, the cap hematology resource committee will be investigating the implementation of grading. College of american pathologists accredited lab baton. Ppt presentation iso 15189 for medical laboratory accreditation. Detailed standards developed based on broad principles defined in the cap standards for laboratory accreditation 21 different checklists with about 2,900 requirements tool for laboratories to prepare for inspection roadmap guide for inspectors to perform an inspection customizable based on tests and activities. Accreditation manual for laboratory related programs by. Laboratory accreditation overview what is laboratory accreditation. Laboratory standards for nextgeneration sequencing clinical tests. For iso or singapore standards, companies can purchase the standards from. Review the abft laboratory accreditation manual and program outline carefully, before completing the accreditation application and selfevaluation checklist. In addition to this anab accreditation manual for laboratory related programs, isoiec 17020, iso 17025, isoiec 17043, iso guide 34, iso 15189, related. Receive cms and internationallyrecognized accreditation for your clinical testing programs. Cap 15189 eceber, 2015 2 backgroundwhy this is necessary the iso 15189.

A2la is the largest and most wellrecognized accreditor of calibration laboratories in the united states. The college of american pathologists biorepository accreditation. Accreditation american association for laboratory accreditation. Cap laboratory accreditation programs professor of pathology and laboratory medicine, rutgers njms and university hospital, newark, nj. The joint commission has helped laboratory organizations across the u. Comprehensive accreditation manual for hospitals n noharm event. Our goal is simple we use our educational laboratory accreditation program to help your laboratory improve quality, efficiency, and achieve compliance.

Competition animal drug testing laboratory accreditation program. Only slightly deviate from epa dw cert manual 1 state kentucky used epa dw cert manualiso 1702540cfr part 6. Colon protocol has been updated requiring reporting of macroscopic evaluation of mesorectum. Comprehensive accreditation manual for hospitals n decreasing variation and defects waste n focusing on achieving better outcomes n using evidence to ensure that a service is satisfactory patient safety emerges as a central aim of quality. Contact usa is pleased to present this revised accreditation manual to all crisis line programs as we continue our program of conducting on.

Published as an early online release august 25, 2014. Patient safety, as defined by the world health organization, is the prevention of errors and adverse effects to patients that are. In addition to this anab accreditation manual for laboratoryrelated programs, isoiec 17020, iso 17025, isoiec 17043, iso guide 34. American association for laboratory accreditation a2la american osteopathic association aoa american society for histocompatibility and immunogenetics ashi cola college of american pathologists cap the joint commission tjc effective date. College of american pathologists laboratory standards for next aug 25, 2014. Grow personally and professionally at the 2020 pathologists leadership summit. Nov 17, 2014 published on nov 17, 2014 management and technical requirements for iso 17025 nabl ukas jas anz dar dakks enas ias accreditation. 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. Our standards for laboratory accreditation the joint. If playback doesnt begin shortly, try restarting your device. In setting evidencebased standards, the guideline provides background and details about the quantitative image analysis qia process and the data and. Our standards for laboratory accreditation the joint commission.