Organizations can request free 90day access to our online standards manual. Anab provides laboratory accreditation to iso 17025 and multiple standards in many industryspecific programs. Disclosed conflicts of the expert panel members are listed in the ap. We offer both print and electronic versions of our laboratory accreditation standards manual. The most current version of the clia regulations part 493, including all changes through 51214. Accreditation accreditation is confirmation that the entity has established, documented, implemented and. All copies paper and electronic of policies and procedures are current.
Master checklist laboratory general medical courier. Guidelines for accreditation of dosimetry calibration laboratories author. Master laboratory general checklist cap accreditation program college of american pathologists 325 waukegan road northfield, il 600932750. The cms cop, which were taken from the state operations manual, appendix asurvey protocol, regulations, and interpretive guidelines for hospitals revised august 20. Updated to reflect lap committee 2015 checklist changes 6. College of american pathologists accredited lab baton rouge. Federal register clia program and hipaa privacy rule. The gastrointestinal and breast protocols have been updated to reflect the revised who histologic types. The information below identifies laboratory accreditation resources at the college of american pathologists. Gen section in the laboratory accreditation manual. The cap s main telephone number is 8003234040 or 8478327000. The laboratory is awarded a cap laboratory accreditation certificate upon successful completion of the inspection process and becomes part of an exclusive group. Iqcp permits the laboratory to customize its qc plan according to test method and use, environment, and personnel competency while providing for equivalent quality testing.
Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care. Refer to the related links outside cms section below for the following information concerning the clinical laboratory improvement amendments clia regulations. Laboratory accreditation manual 2012 edition college of american pathologists maintaining accreditation. Recognizing that laboratory biosecurity is an integral part of biosafety, throughout this document the use of the term biosafety includes laboratory biosecurity appendix a. Appendix c survey procedures and interpretive guidelines for laboratories and laboratory services. Cap releases 2020 edition of laboratory accreditation. This evidence based guideline was developed following the standards endorsed by the. In a release, the college of american pathologists cap released a list of its longest accredited laboratories in the united states. Supplemental requirements for the accreditation of. Effective immediately for all laboratories subject to us regulations. Personnel safety smile general lab safety policy, appendix 4.
The use of this protocol is not required for recurrent tumors or for metastatic tumors that are resected at a different time than the primary tumor. The college of american pathologists february 2020 release includes 47 revised cancer protocols and one new adult autopsy reporting protocol. The laboratory accreditation program lap was established in 1961. Also, if possible, the laboratory should assess its performance on pt challenges that were not graded because of lack of consensus. The georgia environmental protection division has many forms available online, including permit applications, release notifications, and various reporting forms. International laboratory accreditation cooperation ilac, ilac guide 19 guidelines for forensic science laboratories, 2002. Handbook on tuberculosis laboratory diagnostic methods in the. The current cap guidelines and guidances for pathologists provide the latest practice information on pathology and laboratory related topics. Personnel have read the policiesprocedures relevant to their job activities. Measurement uncertainty guide college of american pathologists. With americans now getting the vaccine, testing remains a critical element as we navigate our new normal, says cap president patrick godbey, md. Personnel safety smile lab general safey policy, appendix 3 biosafety appendix 4 audit reference. Master contains all of the requirements and instr uctions a vailable in pdf, wordxml or excel f ormats.
How to write a laboratory quality manual, aphl, may 2017 qms25 handbook for developing a laboratory quality manual,clsi, 2017 world health organization whoclsi. In accordance with the authority in dod directive 56. For accreditation purposes, this protocol should be used for the following procedures and tumor types. This information is on the centers for disease control and prevention cdc website. Anab believes in a partnership approach to laboratory accreditation assessments. Participants of the cap accreditation programs may download the checklists from the cap web site. Organizations can request free 90day access to our online standards manual edition. Clinical laboratory improvement program clip procedures. Includes ptnm requirements from the 8th edition, ajcc staging manual. 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. Cap laboratory accreditation program protocol required use date. Aabb membership is comprised of a diverse community of health care professionals dedicated to making transfusion medicine and cellular therapies safe, available and effective worldwide.
Laboratory accreditation program college of american. The college of american pathologists cap hosted a virtual forum addressing the rapidly changing covid19 testing landscape, the fourth in a series of ongoing media briefings and the first in 2021. The evaluation assesses compliance with our standards and verifies improvement activities. University of texas medical branch pulmonary function clinic policy 0110 compliance with cap terms effective date.
Top laboratory deficiencies across accreditation agencies. November 2020in an association for molecular pathology survey, 62 percent of u. The college of american pathologists pathology and laboratory. Clinical laboratory improvement amendments 42 usc 263a pdf icon external icon source. Guide to cap accreditation for international participants. Protocol for the examination of specimens from patients with. Please contact the appropriate person by phone, mail, or fax. Clsi, 2006 standard operating procedures contd importance of quality control ensures accuracy and reproducibility of lab test results used in patient care. Colon protocol has been updated requiring reporting of macroscopic evaluation of mesorectum. Our standards for laboratory accreditation the joint. These 41 laboratories have continuously met the highest standards of laboratory quality and proficiency testing since the cap began its laboratory accreditation program in 1964, ensuring that patients are receiving the best medical care and most accurate. Laboratory accreditation manual college of american. Master contains all of the requirements and instructions available in pdf, wordxml or excel formats. Welldifferentiated neuroendocrine tumors typical carcinoid tumor of any size should be reported using the cap protocol for neuroendocrine tumors of the appendix.
College of american pathologists 325 waukegan road northfield, il 600932750. To clarify the laboratory s responsibility and the cap s 15189 assessment standards, we have developed this interpretive document for the purposes of accreditation. Discovery of actions by laboratory personnel that violate national state or local regulations. May 2014 gerald hoeltge, md, chair of the cap checklists committee, is pretty sure he knows exactly the way many laboratories will react to a particular change in the latest edition of the laboratory accreditation program checklists, which launch this month.
Protocol for the examination of specimens from patients. Laboratory accreditation manual elab solutions suite is. 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. For guidance on the approach to these situations, refer to appendix i in the cap laboratory accreditation manual for listing of pt exception codes and actions. The laboratory reported 435 patient potassium values in april 2016. Policy pulmonary function laboratories shall comply with the college of american pathologists cap terms of accreditation to maintain accreditation. With every new version of iso 15189, theres a need to update the laboratory approach to obtaining accreditation. Clia regulations and federal register documents cms. Government printing office gpo federal digital system external icon. November 2020 includes ptnm requirements from the 8th edition, ajcc staging manual.
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. As such, the laboratory must first be accredited in the cap lap before. Developed with input from more than 500 pathologists and laboratory experts, our 21 disciplinespecific accreditation checklists provide a clear roadmap for not only achieving accreditation but also for running a highquality laboratory. The aoac international guidelines for laboratories performing microbiological and chemical analyses of food, dietary supplements, and pharmaceuticals, an aid to interpretation of isoiec 17025. Throughout the laboratory accreditation process, we focus on customer needs while ensuring all iso 17025 laboratory accreditation requirements are met. Dec 31, 2019 appendix c survey procedures and interpretive guidelines for laboratories and laboratory services. Master laboratory general checklist college of american. Par ticipants of the cap accreditation prog rams ma y do wnload the chec klists from the cap web site. Cap biorepository accreditation program checklist master. Cap lab accreditationchecklistsprotocolsguidelines. If you are enrolled in the caps laboratory accreditation program and are. Laboratory accreditation manual ut health san antonio. Erlntb network, in 2014 ecdc commissioned a renewal of the network now called.
Survey procedures and interpretive guidelines for laboratories and laboratory services, appendix c. The analytical laboratory accreditation criteria committee alacc. Supplement to the laboratory quality management system training toolkit, quality manual, version, 20. Aoac accreditation guidelines for laboratories alacc. Cap 15189 eceber, 2015 2 backgroundwhy this is necessary the iso 15189. Notice terminating march 31, 2020 guidance regarding covid19 implications for epds compliance and enforcement. This report describes the important issues considered by the cap. The clinical laboratory improvement amendments of 1988 statute is an amendment to the public health services act in which congress revised the federal program for certification and oversight of clinical laboratory testing. Best practices for maintaining quality in molecular. College of american pathologists laboratory standards for next. Us department of commerce, national technical information service, springfield, va, 1992, p.
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. Lanl engineering standards manual pd342 chapter 17 pressure safety section d20b31. For accreditation purposes, this protocol should be used. Laboratory accreditation manual university of texas health. Accreditation and certification require an onsite evaluation by the joint commission. Supplemental requirements for the accreditation of forensic. The caps main telephone number is 8003234040 or 8478327000. In total, clia covers approximately 254,000 laboratory enes. Like that of so many pathologists, my introduction to the cap came through the laboratory accreditation program. Immediate notification of cap is required and shall be given for the. Bone marrow synoptic reporting for hematologic neoplasms.
Our standards for laboratory accreditation the joint commission. They are available in different checklist types and formatting options, including. Current cap guidelines college of american pathologists. Personnel safety smile lab general safety policy, appendix 2 fire safety appendix 3 audit reference. The laboratory accreditation manual is intended to provide laboratories and inspectors a basic. Regulatory and accreditation requirements college of american pathology general and all common checklists july 2012 gen. Laboratory general, all common, anatomic pathology, team leader assessment of director and quality deficiencies timelines preparation for inspection. Practical guide to specimen handling in surgical pathology.
International organization for standardization iso 15189. Lab manual appendix c lab report format and sample report. February 2020 cap laboratory accreditation program protocol required use date. Sep 11, 2010 american society of crime laboratory directors laboratory accreditation board ascld lab, accreditation manual, 2008. Blood gas laboratory compliance with cap terms of 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. Cancer protocol templates college of american pathologists. Cap must be notified as soon as laboratory finds itself to be subject to validation inspection. For the first few labs, students must submit individual reports, although for later experiments, a team may only have to submit one report.
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