COLA LABORATORY Accreditation Manual - …

1 cola LABORATORYA ccreditation ManualAPRIL 2017 cola Accreditation PROGRAM 2017 cola | PHONE | FAX | EMAIL | WEB | ISODOC 53-162 Professional External Assessment Program Focused on LABORATORY Quality and Performance ExcellenceThe purpose of this Accreditation Manual is to provide you with the information and help you need to successfully participate in cola s LABORATORY Accreditation program and become a high performing medical Manual will help you understand how the cola Accreditation process works, familiarize you with the standards and responsibilities a LABORATORY must meet to ensure compliance, and describe how cola and its staff of professionals can support you as you strive for the following pages you will find a detailed but easy-to-follow description of the cola Accreditation program, including: The sequence of steps required to complete cola Accreditation and what s involved.

2 The relationship between cola , CLIA, and regulatory bodies such as CMS and state agencies. A description of the roles of LABORATORY staff in supporting the Accreditation process and important actions you need to take. cola Criteria for Quality LABORATORY Performance. An overview of the resources available to answer your questions and help you develop a compliance strategy that works for your of RevisionsDeletionsLDR 6, WAV 10 Revisions:WAV 1, CA 1, FAC 8, PER 3, MSPEC 3, MSPEC 4 Additions:CA , QA , MSPEC , , , 8, 9, 10, 11 Fast AnswersYou can use this Manual to help you find answers phone number: 800-981-9883, Monday through Friday, 9 to 5 EST.

3 Email address: s customer portal: of Contents, page 3 Helpful tips, learning points, highlight boxes, reminders included throughout this ManualBenefits of cola Accreditation Improved patient safety More accurate LABORATORY results Compliance with regulatory standards Evidence of quality LABORATORY practices More efficient, productive LABORATORY operations Improved customer satisfaction Ongoing monitoring of proficiency testing cola Accreditation PROGRAM 2017 cola | PHONE | FAX | EMAIL | WEB | ISODOC 53-163I. Introduction to AccreditationForward: Message from cola CEO.

4 5 cola Accreditation An Introduction and Overview ..6 Laboratories Eligible for cola Accreditation ..6 The VALUE of cola Accreditation ..7 Here s How to Contact cola and Get Help Fast ..8 cola , Regulatory Compliance, and Your LABORATORY ..9II. cola Accreditation : How it Works, What to DoThe Road to Accreditation : Important Facts You Need to 1: Enrollment and Completion of Forms ..20 Step 2: Completing the Self-Assessment ..21 Step 3: On-site Survey ..22 Step 4: Post-Survey and Corrective Action ..27 Step 5: Accreditation ..30 III. cola Criteria for Quality LABORATORY PerformanceOverview: cola Criteria for Quality LABORATORY Performance and Self-Assessment Questions.

5 37 The Criteria and Self-Assessment Follow the Path of Workflow ..37 About the Self-Assessment Questions ..38 Essential (E) vs. Required (R) Criteria ..38 The Criteria Cover Evaluation Groupings In the LABORATORY Path of Workflow ..39 Understanding the Criteria and Completing The Self-Assessment: Helpful Information By Evaluation Grouping ..40 Transfusion Services Criteria ..152IV. Educational Resources and SupportLabUniversity On-Line Continuing Education ..172 Lab Director CME Program for Physicians ..173 Symposium for Clinical LaboratoriesTM ..173 Educational Publications and Products.

6 173 Continuous Quality Program ..173 Other Internet Resources ..174V. Appendix ..175 Accreditation Quick Look:What s InvolvedYou complete a series of steps on your road to Accreditation :INFORMATION GATHERING AND Upfront, you supply cola with information about your LABORATORY You become familiar with the steps in Accreditation and responsibilities in the process You conduct a detailed self-assessment of your LABORATORY operations, reporting the data to cola You make sure you meet other requirements of state and federal agencies You have proficiency testing data released to cola and respond to notices of unsuccessful performance ON-SITE cola conducts an on-site survey to assess your LABORATORY s complianceFEEDBACK AND cola experts provide you with feedback on your LABORATORY s operation.

7 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 of noncompliance and takes corrective action You provide documented proof of improvements to cola CONGRATULATIONS! When cola has determined that you are compliant with all of its criteria, your LABORATORY is granted Accreditation PROGRAM 2017 cola | PHONE | FAX | EMAIL | WEB | ISODOC 53-164 This Manual provides all the detailed information you need to become accredited with cola .

8 To help you make efficient use of your time, we have included a mini table of contents for each major section, complemented by easy-to-follow flow charts, quick tips, highlighted boxes, and key learning points throughout the text to help you quickly grasp what s most important for your LABORATORY to know and do during the Accreditation contents of the Accreditation Manual are organized into a logical path that consists of the following sections:Section I: Introduction to AccreditationHere, the cola CEO introduces you to the unique and value-added aspects of cola Accreditation , accompanied by an overview of cola , its range of services, and its historical involvement in Accreditation .

9 In this section, you ll also enhance your understanding of the benefits of Accreditation , the authority of cola as an Accreditation organization in the CLIA regulatory process, and the responsibilities your LABORATORY and cola are required to II: cola Accreditation , Step-by-Step: How it Works, What You DoCOLA has developed a multi-step process to complete Accreditation . This section of the Manual walks you through the steps on the road to Accreditation . Here, you will find all the information you need 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 LABORATORY PerformanceIn this section, you ll learn about all the criteria your LABORATORY must meet to become accredited.

10 The Self-Assessment introduces you to the cola criteria and is an integral part of the cola Accreditation IV: Educational Resources and SupportEducational resources support and assistance are cola s strengths. Here you ll learn about the wide array of resources and tools available through cola and its subsidiary cola Resources Inc., that can help build your V: AppendixHere you ll find reference and support materials related to subjects covered in the content of the Tips! How to use this you read through this Manual , look for icons like the ones described below, as well as the many quick tip features you ll see, because they provide helpful hints or alert you to information that is important for you to THIS SECTION The first page of each section in this Manual has its own In This Section table of contents identified by the icon.