COLA LABORATORY ACCREDITATION MANUAL

1 cola LABORATORYACCREDITATION MANUAL > JUNE 2012 See page 2 for asummary of revisionsto the COLAA ccreditation Professional External Assessment Program Focused onLaboratory Quality and Performance Excellence The purpose of this ACCREDITATION MANUAL is to provide you with the infor-mation and help you need to successfully participate in cola s laboratoryaccreditation program and become a high performing medical MANUAL will help you understand how the cola ACCREDITATION processworks, familiarize you with the standards and responsibilities a LABORATORY mustmeet to ensure compliance, and describe how cola and its staff of profes-sionals can support you as you strive for ACCREDITATION . On the following pages you will find a detailed, but easy-to-follow descriptionof the cola ACCREDITATION program, including: The sequence of steps required to complete cola ACCREDITATION andwhat s involved The relationship between cola , CLIA, and regulatory bodies such as CMSand state agencies A description of the roles of LABORATORY staff in supporting the accredita-tion process and important actions you need to take cola Criteria for Quality LABORATORY Performance Comprehensive information about the many cola educational opportunities available to enhance staff knowledge and skills An overview of the resources available to answer your questions and help you develop a compliance strategy that works for your AnswersYou can use this MANUAL to help youfind answers Call Center phone number:(800) 981-9883, Monday throughFriday, 9 to 5 , EST.

2 E-mail address: Educational of Contents, page 3 More Contact information, page 1-4 Helpful tips, learning points, highlightboxes, and reminders includedthroughout this MANUAL As a handy reference, please writeyour cola ID number here: 000000 Benefits of cola ACCREDITATION Improved patient safety More accurate LABORATORY results Compliance with regulatory standards Evidence of quality LABORATORY practices More efficient, productive laboratoryoperations Improved customer satisfaction Ongoing monitoring of proficiencytesting> cola ACCREDITATION PROGRAM2 2012 cola CONTACT COLAPHONE |FAX |ON-LINE ..Summary of Revisions:Additions:noneDeletions:noneRe visions:FAC 9, 13, 14, 15, 16; PER 2, 3, 5; PT 8; PRE 7, 11; APM 15, 18;MA 23; VER 4, 8; CA 1; QC 1, 10, 16, 21; PST 16, 20, 24, 25, 26;QA 2, 3, 5, 6, 12 For more information about these revisions, see our technical bulletin Introduction to AccreditationForeword: Message from cola CEO.

3 1-1 cola ACCREDITATION An Introduction and Overview .. 1-2 Laboratories Eligible for cola ACCREDITATION ..1-2 The VALUE of cola ACCREDITATION ..1-3 Here s How to Contact cola and Get Help Fast ..1-4 cola , Regulatory Compliance, and Your LABORATORY .. 1-5II cola ACCREDITATION : How It Works, What to DoThe Road to ACCREDITATION : Important Facts You Need to Know ..2-3 Step 1: Enrollment and Completion of Forms ..2-6 Step 2: Completing the Self-Assessment ..2-7 Step 3: On-site Survey ..2-8 Step 4: Post-Survey and Corrective Action ..2-12 Step 5: ACCREDITATION ..2-15 III cola Criteria for Quality LABORATORY PerformanceOverview: cola Criteria for Quality LABORATORY Performance and Self Assessment Questions ..3-2 The Criteria and Self-Assessment Follow the Path of Workflow ..3-2 About the Self-Assessment Questions and Answer Sheet ..3-3 Essential (E) vs. Required (R) Criteria ..3-3 The Criteria Cover 14 Main Evaluation Groupings in the LABORATORY Path of Workflow.

4 3-4 Understanding the Criteria and Completing the Self-Assessment: Helpful Information by Evaluation Grouping ..3-5 Additional Criteria ..3-93IV Educational Resources and Support cola s LabUniversity On-Line Continuing Education .. 4-1 Educational Publications and Information Sheets ..4-2 Additional cola ProgramsSymposium for Clinical Laboratories ..4-2 cola s LABORATORY Director Program for Physicians ..4-2 Other Internet Resources ..4-3V Appendix ..5-1 ACCREDITATION Quick Look:What s Involved You complete a series of steps on yourroad to ACCREDITATION :INFORMATION GATHERING AND Upfront, you supply cola with information about your LABORATORY You become familiar with the steps inaccreditation and responsibilities in theprocess You conduct a detailed self-assessmentof your LABORATORY operations, reportingthe data to cola You make sure you meet otherrequirements of state and federalagencies You have your proficiency testing datareleased to cola and respond tonotices of unsuccessful performanceON-SITE cola conducts an on-site survey toassess your LABORATORY s complianceFEEDBACK AND cola experts provide you with feedback on your LABORATORY s opera-tion, including identification of noncompliances that need to be corrected cola experts provide you with experienced guidance in the correction of noncompliant criteria Your LABORATORY addresses areas ofnoncompliance and takes correctiveaction You provide documented proof of improvements to COLACONGRATULATIONS!

5 When cola has determined that youare compliant with all of its criteria,your LABORATORY is granted ACCREDITATION >TABLE OF CONTENTS3 2012 cola CONTACT COLAPHONE |FAX |ON-LINE ..This MANUAL provides all the detailed information you need tobecome accredited with cola . But to help you make efficient useof your time, we have included a mini table of contents for eachmajor section, complemented by easy-to-follow flow charts, quicktips, highlight boxes, and key learning points throughout the text tohelp you quickly grasp what s most important for your laboratoryto know and do during the ACCREDITATION contents of the ACCREDITATION MANUAL are organized into a logicalpath that consists of the following sections:Section I: Introduction to AccreditationHere, the cola CEO introduces to you to the unique and value-added aspects of cola ACCREDITATION , accompanied by an overviewof cola , its range of services, and its historical involvement inaccreditation.

6 In this section, you ll also enhance your understandingof the benefits of ACCREDITATION , the authority of cola as anaccreditation organization in the CLIA regulatory process, andthe responsibilities your LABORATORY and cola are required to II: cola ACCREDITATION , Step-by-Step: How itWorks, What You Do cola has developed a multi-step process to complete section of the MANUAL walks you through the steps on theroad to ACCREDITATION . Here, you will find all the information youneed to know to get started with ACCREDITATION and what your LABORATORY and your staff need to do to support the III: cola Criteria for Quality LaboratoryPerformanceIn this section, you ll learn about all the criteria your LABORATORY mustmeet to become accredited. The Self-Assessment introduces you tothe cola criteria and is an integral part of the cola accreditationprocess. Section IV: Educational Resources and Support Educational resource support and assistance are cola s you ll learn about the wide array of resources and tools available through cola that can help build your knowledge.

7 Section V: Appendix Here you ll find reference and support materials related to subjectscovered in the content of the MANUAL . Helpful Tips! How to use this you read through this MANUAL , lookfor icons like the ones described below,as well as the many quick tip featuresyou ll see, because they provide helpfulhints or alert you to information that isimportant for you to THIS SECTION The first pageof each section in this Manualhas its own In This Section tableof contents identified by the icon. The Table of Contents canbe a useful guide for findinginformation quickly. ACTION REQUIRED Thesebrief items will point out importantactions your LABORATORY needs totake as part of the TIPS Quick tips arelocated throughout the text andprovide helpful information andreminders, or things to POINTS This appleicon identifies key learning pointsas you strive to educate yourselfand your staff about A GLANCE Look for thisicon for a quick summary of keypoints in the section.

8 >KEY FEATURES OF YOUR ACCREDITATION MANUAL4 2012 cola CONTACT COLAPHONE |FAX |ON-LINE ..IN THIS SECTIONF oreword: Message from cola CEO ..1-1 cola ACCREDITATION An Introduction and Overview ..1-2 Laboratories Eligible for cola ACCREDITATION ..1-2 The VALUE of cola ACCREDITATION ..1-3 Here s How to Contact cola and Get Help Fast ..1-4 cola , Regulatory Compliance, and Your LABORATORY ..1-5 FOREWORD: MESSAGE FROM cola CEOBy Douglas A. Beigel, Chief Executive Officer cola ACCREDITATION : Built on a Foundation of Education and Partnership with the Medical CommunityWelcome and congratulations on your decision to participate in the cola LABORATORY ACCREDITATION professionals have found cola s ACCREDITATION program to be an excellent quality improvement and educationaldevelopment process, as well as an effective and convenient way to meet the LABORATORY regulations mandated by theClinical LABORATORY Improvement Amendments (CLIA) of 1988.

9 cola standards have been developed by clinical laboratoryprofessionals and are based on practical, proven methods and accepted good LABORATORY practices that meet s commitment to excellence in ACCREDITATION is built on a foundation of education and partnership with the medicalcommunity. One of the truly unique aspects of the cola ACCREDITATION program is its focus on education. You ll grow yourknowledge of LABORATORY processes through cola s ACCREDITATION program and can fulfill your learning and training needswith cola educational products, including on-line courses offered through our LabUniversity .We ve made our ACCREDITATION process as straightforward as possible preparing and educating you step-by-step, always usingclearly understood requirements and working with you to develop a compliance strategy that works for your important feature of cola ACCREDITATION is its emphasis on partnership. ACCREDITATION success comes with teamwork,and as you travel along the road to ACCREDITATION , cola will provide guidance and support to you every step of the staff is knowledgeable, accessible, approachable, and readily available to help you.

10 You ll receive guidance and feedbackfrom cola staff that will help you gauge your progress, offering suggestions for improvement and achievement of full encourage you to take full advantage of this MANUAL and the many other learning tools and educational opportunitiesCOLA will make available to you and your staff during the ACCREDITATION process. We provide the tools and education to helplaboratories succeed. But success will depend on the effort you and your staff put into the ACCREDITATION process. We have attempted to make this MANUAL as comprehensive as possible. However, if you have questions about the accreditationprocess or our services, contact our Call Center at (800) luck on your journey to ACCREDITATION !>SECTION I: INTRODUCTION TO ACCREDITATION1-1 2012 cola CONTACT COLAPHONE |FAX |ON-LINE .. cola ACCREDITATION An Introduction and OverviewThe cola ACCREDITATION program is educationally oriented. cola s mission is to help physicians, clinical LABORATORY professionals,and healthcare staff to operate accurate and efficient laboratories.