Laboratory Accreditation Manual - Pathology

1 Editor: Francis E. Sharkey, MD, FCAPL aboratory Accreditation ManualPatient Safety | Compliance | Consistency | Confidence | Accuracy | 2017 College of American Pathologists. All rights reserved. College of American Pathologists Laboratory Accreditation Manual 2017 Edition 1 TABLE OF CONTENTS TOPIC PAGE Introduction 3 Commission Philosophies 10 Applying to CAP Accreditation Programs 14 Preparation of Application Materials 16 Preparing for the Inspection 21 Conducting the Inspection: General Principles and Meetings 29 Inspecting the Laboratory Sections 40 Requirements Applicable to all Laboratory Sections Laboratory General Conducting the Safety Inspection All Common Anatomic Pathology 40 42 48 53 63 Chemistry and Toxicology 69 Clinical Biochemical Genetics Cytogenetics 72 75 Cytopathology 78 Flow Cytometry 84 Hematology and Coagulation 86 Histocompatibility 90 Immunology 93 Microbiology 94 Molecular Pathology 99 Point-of-Care Testing 102 Team Leader Assessment of Director & Quality Checklist 106 Transfusion Medicine 109 Urinalysis 111 Reproductive Laboratories (RLAP) 112 Forensic Drug Testing Laboratories (FDT) Biorepository Facilities (BAP)

2 115 117 Inspecting Other Types of Laboratories 120 The Inspection Report 125 The Summation Conference 126 Post-Inspection for the Inspection Team 131 Post-Inspection for the Laboratory 132 Maintaining Accreditation 139 Nonroutine Inspections 145 Appendices 148 Appendix A: CAP Checklist Usage 148 Appendix B: Guidelines for Determining Test Volume 154 College of American Pathologists Laboratory Accreditation Manual 2017 Edition 2 TABLE OF CONTENTS TOPIC PAGE Appendix C: Announced and Unannounced Inspections: Tips for Laboratories and Site Coordinators 156 Appendix D: Sample of Inspection Confirmation Letter to Laboratory Director Appendix E: Laboratory General Activity Menu Reference Guide 160 163 Appendix F: Retention of Laboratory Records and Materials 165 Appendix G: Glossary of Terms 168 Appendix H: Accreditation Requirements When a PT Result Is Linked to an Exception Reason Code 189 Appendix I: CAP Accreditation Program Policies 192 College of American Pathologists Laboratory Accreditation Manual 2017 Edition 3 INTRODUCTION TOPIC PAGE Purpose of this Manual 3 Overview of Accreditation Program 3 Accreditation Hierarchy 4 Commissioners 5 Inspectors and CAP Staff 5 Accreditation Documents 5 Communication of Changes to CAP Accreditation Programs 6 Standards for CAP Accreditation Programs 6 Accreditation Checklists 6 Identifying Checklist Changes 7 Phase 0, Phase I, and Phase II Deficiencies 8 Checklist Components 8 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.

3 The detailed Accreditation requirements used for inspection are found in the CAP s Accreditation checklists. CAP-accredited laboratories and biorepositories must be in compliance with the checklist version effective at the time of application or reapplication. Requirements published in the checklists supersede information published in this Manual . Overview of Accreditation Programs The College of American Pathologists (CAP) has established and currently directs multiple Accreditation programs. The Laboratory Accreditation Program (LAP) was established in 1961. In 1995, the Centers for Medicare and Medicaid Services (CMS), an agency within the US Department of Health and Human Services, approved the CAP as an accrediting organization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CAP Laboratory Accreditation offers the broadest scope of disciplines of any approved Accreditation program. Other CAP Accreditation programs and year of introduction include: Forensic Drug Testing (FDT) in 1988, Reproductive Laboratory Program (RLAP) in 1993, and the Biorepository Accreditation Program (BAP) in 2011.

4 In 2008, the CAP established the CAP 15189 program, a voluntary nonregulated Accreditation program related to the International Organization for Standardization (ISO) 15189:2007 Standard. CAP 15189 has its own standards and policies not addressed in the Laboratory Accreditation Manual . It does not replace the CLIA-based Laboratory Accreditation Program College of American Pathologists Laboratory Accreditation Manual 2017 Edition 4 (LAP), but rather complements LAP and other quality systems by optimizing processes to improve patient care, strengthen deployment of quality standards, mitigate risk, and control costs. The four Laboratory Accreditation programs (LAP, BAP, FDT, and RLAP) were all created with the primary objective of improving the quality of clinical Laboratory services. They employ voluntary participation, professional peer review, education, and compliance with established performance standards. Since their creation, these programs have become widely acknowledged for excellence.

5 In total, the CAP accredits more than 7,800 laboratories. The Accreditation programs are based on rigorous Accreditation standards that are translated into detailed checklist requirements. CAP inspection teams use the checklists as a guide to assess the Laboratory 's overall management and operation. With the checklists as a guide, inspectors examine preanalytic, analytic, and postanalytic aspects of quality management (QM) in the Laboratory . 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. The programs are internationally recognized and are the only ones that utilize teams of practicing Laboratory professionals as inspectors.

6 Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence and positively impact patient care. Accreditation Hierarchy The Council on Accreditation (CoA) sets the strategic direction for the CAP s Laboratory 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 provides oversight to the Commission on Laboratory Accreditation (CLA), a group of qualified pathologists appointed to advance the CAP s Accreditation programs as the prime exemplar for the inspection and Accreditation of medical laboratories and biorepositories; to administer the programs through the principles of peer review and education; to further the goal of Laboratory improvement in order that quality Laboratory services are provided to patients and clients; to ensure that the programs continue to meet the scientific, service, and regulatory needs of participants; and to enhance the recognition of the pathologist Laboratory director s role in clinical decision making and consultation.

7 The CLA oversees and coordinates the activities of the five CLA committees in the development, maintenance, and implementation of (i) Accreditation checklists and standards, (ii) the inspection processes, (iii) inter-inspection assessment tools, (iv) complaint investigations, and (v) program education. The CLA also ensures that committee priorities and activities are aligned with the overall goals, strategies, and tactics supporting the CAP s Accreditation programs. The CLA uses the expertise of numerous CAP scientific resource committees to keep the programs and their requirements abreast of new developments in Laboratory medicine. College of American Pathologists Laboratory Accreditation Manual 2017 Edition 5 The Accreditation Committee is another arm of the CoA, and is responsible for ensuring objectivity and consistency in CAP Accreditation decisions by centralizing the decision-making process and criteria. The Accreditation Committee is responsible for all Accreditation status decisions, including suspension and probation, based on the recommendations from the reviewing commissioners, technical specialists, and other LAP committees as appropriate.

8 Commissioners Many of the members of the CLA and LAP Committees also serve as regional commissioners. Each regional commissioner is responsible for the Accreditation activities of a specified group of laboratories. This includes the timely assignment of inspectors, review of inspection findings, and presentation of Accreditation issues to the Accreditation Committee. Following the on-site inspection, the regional commissioner, in conjunction with CAP technical staff, reviews the inspection findings and the Laboratory s corrective action, and contributes to any follow-up necessary to reach an Accreditation decision. Deputy, state, and division commissioners assist the regional commissioners. State and division commissioners are responsible for validating proposed inspector matches for the laboratories in their geographic regions. They are assisted by CAP staff to ensure that inspections are timely and in accordance with Accreditation Program policy.

9 They are responsible for providing feedback and mentoring to volunteer inspectors. Inspectors and CAP Staff The inspectors who conduct the on-site Laboratory inspections are the lifeblood of the program. Typically, the inspection team leader is a board-certified pathologist who has received training and has participated in several inspections as a team member. Inspection team members are other pathologists, doctoral scientists, supervisory-level medical technologists, Pathology residents and fellows, and other individuals who have been trained in CAP inspection requirements and have expertise in the area of the Laboratory that they inspect. The Laboratory Accreditation staff at the CAP headquarters in Northfield, Illinois, comprises technical and administrative personnel who carry out the policies and procedures of the CLA and who are responsible for the management and operation of the program. They include a limited number of full-time inspectors who conduct inspections that meet defined criteria.

10 Accreditation Documents In addition to this Manual , three other documents are fundamental to the inspection process: 1) the Standards for Laboratory Accreditation (the Standards), 2) the Accreditation Checklists, and 3) the Inspector s Summation Report (ISR). Through peer review, the inspector uses the checklists to determine if the Laboratory meets the criteria set out in the Standards. The inspector collects information and records it on the ISR, and this information is the basis for the regional commissioner s Accreditation recommendation. In addition to verifying that regulatory requirements are being met, the inspection entails sharing of information and ideas between the members of the inspection team and the staff of the Laboratory being inspected. This sharing of information results in ideas for Laboratory improvement for all concerned, and the inspection team members often take new ideas or processes back to their own laboratories.