Transcription of Laboratory Accreditation Manual
1 Laboratory Accreditation ManualPatient Safety | Compliance | Consistency | Confidence | Accuracy | QualityGerald A. Hoeltge, MD, 112/5/19 10:24 AM Contacting the CAP Accreditation Programs Laboratories may contact the LAP with questions on Accreditation -related topics by: Email: Phone: 800-323-4040 or 847-832-7000. CAP Accreditation business hours are 8:00 AM 5:00 PM Central Time, Monday through Friday, excluding holidays. Mail: CAP Accreditation Programs College of American Pathologists 325 Waukegan Road Northfield, IL 60093 For specific Accreditation topics, laboratories can submit questions to or contact the CAP Accreditation staff by phone (800-323-4040 or 847-832-7000) at the extensions listed below.
2 Topic Extension Interpretation of checklist items Responding to deficiencies Technical review of deficiencies 6065 Inspector demographic changes Reimbursement for inspection Specialty inspector 7380 Systems inspections 7290 Staff inspector information 7279 Proficiency testing enrollment Proficiency testing participation Performance compliance notices CAP-accepted proficiency testing programs 6052 Accreditation Resources in e-Lab Solutions Suite The CAP is constantly seeking new ways to help guide your Laboratory through the Accreditation process.
3 We recently revised and expanded our resources to make it easier to find the answers you seek. New content includes checklist Q & A s written by technical specialists, and an informative Inspection Prep course. What s more, everything is fully searchable, so you can quickly find what you need. Simply log in to the e-LAB Solutions Suite whenever you have an Accreditation question. Continued on inside back cover College of American Pathologists Laboratory Accreditation Manual 2020 Edition 1 TABLE OF CONTENTS TOPIC PAGE Introduction 2 Accreditation Program Types 6 Commission Philosophies 10 Applying to CAP Accreditation Programs 14 Inspection Options 20 Preparing for the Inspection: Laboratory 25 Preparing for the Inspection: Inspection Team 29 Proficiency Testing: Enrollment and Handling 39 Proficiency Testing: Failures and Monitoring 42 Accreditation Checklists 46 Conducting the Inspection.
4 General Principles and Meetings 51 After the Inspection: Inspection Team 67 After the Inspection: Laboratory 69 Maintaining Accreditation 76 Non-Routine Inspections 81 Complaints and Investigations 82 Accreditation Program Requirements for International Laboratories 84 Appendices 89 Appendix A: Accreditation Checklists Overview 89 Appendix B: Instructions for Determining Test Volume 96 Appendix C: Retention of Laboratory Records and Materials 99 Appendix D: Glossary of Terms 102 Appendix E: CAP Accreditation Program Website Tools 117 College of American Pathologists Laboratory Accreditation Manual 2020 Edition 2 INTRODUCTION TOPIC PAGE Purpose of this Manual 2 Overview of Accreditation Programs 2 Accreditation Program Organization 3 Commissioners 3 Inspectors and CAP Staff 4 Accreditation Documents 4 Standards for CAP Accreditation Programs 4 Accreditation Checklists 5 Purpose of this Manual The Laboratory Accreditation Manual provides laboratories and inspectors a basic overview on the CAP s Accreditation
5 Programs and Accreditation processes. Overview of Accreditation Programs The College of American Pathologists Accreditation programs provide an engaging, dynamic and collaborative process that fosters an environment of continuous improvement. A description of each of these programs is included in the Accreditation Program Types section. The Accreditation programs were created with the primary objective of improving the quality of clinical Laboratory services through voluntary participation, professional peer review, year-round education, and compliance with established performance standards.
6 Since their creation, these programs have become widely acknowledged for excellence. In total, the CAP accredits more than 8,000 laboratories in 53 countries. The Accreditation programs are based on rigorous Accreditation standards translated into detailed checklist requirements that provide a clear roadmap not only to achieve Accreditation but also for running a high-quality Laboratory . CAP inspection teams use the checklists as a guide to assess the Laboratory 's overall management and operation. Inspectors examine preanalytic, analytic, and postanalytic aspects of quality management (QM) in the Laboratory .
7 These include the performance and monitoring of general quality control (QC); test methodologies and specifications; reagents, controls, and media; equipment; specimen handling, test reporting and internal performance assessment; and external proficiency testing. In addition, personnel requirements, safety, document management, and other administrative practices are included in the inspection process. College of American Pathologists Laboratory Accreditation Manual 2020 Edition 3 The programs are internationally recognized and are the only ones that utilize teams of practicing Laboratory professionals as inspectors for all Laboratory disciplines.
8 Designed to go well beyond regulatory compliance, the programs help laboratories utilize best practices while achieving the highest standards of excellence to have a positive impact on patient care. Accreditation Program Organization The Council on Accreditation (CoA) sets the strategic direction for the CAP s Accreditation programs, in accordance with the CAP s vision, and monitors its overall effectiveness in ensuring that participating laboratories meet regulatory and CAP requirements. The CoA also oversees the Commission on Laboratory Accreditation (CLA), a group of qualified pathologists appointed with the following charges.
9 Advance the CAP s Accreditation programs as the prime exemplar for the inspection and Accreditation of clinical laboratories and biorepositories Administer the programs through the principles of peer review and education Further the goal of Laboratory improvement in order that quality Laboratory services are provided to patients and clients Ensure that the programs continue to meet the scientific, service, and regulatory needs of participants Enhance the recognition of the pathologist Laboratory director s role in clinical decision making and consultation.
10 The CLA oversees and coordinates the activities of five CLA committees in the development, maintenance, and implementation of Accreditation checklists and standards, the inspection processes, inter-inspection assessment tools, complaint investigations, and program education. The CLA also ensures that committee priorities and activities are aligned with the overall goals and strategies supporting the CAP s Accreditation programs. The CLA uses the expertise of numerous CAP scientific resource committees to keep the programs and their requirements up to date with the latest best practices as new advances and technology become part of the modern Laboratory workflow.
