CLIA Compliance Manual - bioMérieux

1 clia . Compliance Manual Part # 410382 bioM rieux . VIDAS. Series Analyzer In association with Mary Blount, , MT (ASCP). Ann Bachman, , CLC (AMT), MT (ASCP). DoctorsManagement 10401 Kingston Pike Knoxville, TN 37922. Phone: (865) 531-0176. Fax: (865) 531-0722. NOTICE. This clia Compliance Manual contains policies and procedures to help you comply with the final Clinical Laboratory Improvement Amendments, which became effective on April 24, 2003. We hope this Manual becomes a valuable tool for you and your laboratory staff. Before using the VIDAS . Series Analyzer, customize this clia Compliance Manual to reflect the actual circumstances in your laboratory by entering your laboratory's protocol in the spaces indicated. This Manual is designed to provide accurate and authoritative information in regard to the subject matter covered. Because procedures are subject to occasional change, always refer to the test package insert for the most current information and modify this Manual accordingly.

2 (From a Declaration of Principles jointly adopted by a Committee of the American Bar Association and a Committee of Publishers.). Unless otherwise noted, no part of this book or provided material may be reproduced, stored in a retrieval system, or transmitted, in whole or in part, in any form, or by means, to include but not limited to: electronic, mechanical, photocopying, recording, and distributed to non-bioM rieux customers without prior written permission of DoctorsManagement, 10401 Kingston Pike, Knoxville, TN 37922. and bioM rieux . All rights reserved 2010. Exception Practices that have acquired this material through DoctorsManagement and bioM rieux may reproduce forms for use within their practice. Individuals who have acquired the materials through the above entities including bioM rieux or one of its South American subsidiaries may reproduce forms to be used within their place of employment under the same conditions as above. Disclaimer The chapters of this Manual have been made available to you in PDF format.

3 Some chapters of this clia Compliance Manual contain links to websites referred to in the material. Most links will connect with the referenced site correctly, but due to settings of individual websites, some may not. The document called clia Contact List is correct but will not link due to the nature of how it was reproduced. Neither bioM rieux nor DoctorsManagement has control of websites maintained by outside agencies. If a link does not take you to the correct website, try typing the website link address into your Internet search engine, or use the agency's telephone contact information if it is available. All links were verified as correct at the time of publication. DOCTORSMANAGEMENT. 10401 KINGSTON PIKE. KNOXVILLE, TN 37922. PHONE: (865) 531-0176 FAX: (865) 531-0722. Trademarks bioMeri ux, SPR, and VIDAS are used, pending and/or registered trademarks belonging to bioMeri ux, SA, or one of its subsidiaries. 2. ABOUT THE AUTHORS. Mary Blount Ms.

4 Blount joined the DoctorsManagement OSHA- clia team in 2006 and is contributing her experience in lab management. She provides advice as a technical consultant, trains lab personnel, and guides physician offices with OSHA- clia Compliance regulations. She currently serves as the Laboratory Director for three non-waived physician office laboratories. Ms. Blount is experienced in managing a moderate-complexity lab, and currently is on a NDMS. forensic team that responds to federal disasters involving loss of life. Her role on that team is DNA. testing and information resources. She responded most recently to the Katrina disaster. Ms. Blount earned her degree from Mississippi State University, and she is licensed as a Medical Technologist by the American Society of Clinical Pathologists. Ms. Blount also has experience in industrial chemistry, and has completed hazmat training. M. Ann Bachman Ms. Bachman is an OSHA- clia Specialist with DoctorsManagement and serves as the Executive Director for the American Association of Physician Offices and Laboratories (AAPOL).

5 She has extensive experience in clinical testing, laboratory management and supervision, patient and employee education, marketing, customer service, and leadership. She speaks nationally on regulatory Compliance issues involving the Clinical Laboratory Improvement Amendments of 1988 ( clia 88), Coding and Billing for the Physician Office Laboratory, and the Occupational Safety and Health Administration (OSHA) regulations. Ms. Bachman serves as the technical consultant for numerous physician office laboratories and serves as an advisor to other laboratory-oriented entities. Her articles have appeared in the POL-News, Advance for Laboratory Professionals, and MGMA Update. She is a regular contributor to the AAPOL News newsletter and other trade journals. Ms. Bachman has taught continuing education courses at the community college level. She provides hotline services for AAPOL members. She also is a former president of the East Tennessee Society of Clinical Laboratory Science.

6 She earned her from the University of Tennessee. Ms. Bachman is professionally licensed as a Medical Technologist by the American Society of Clinical Pathologists and is a Certified Laboratory Consultant through the American Medical Technologists. She is an associate member of the National Association of Healthcare Consultants. Prior to joining DoctorsManagement (formerly RCFA Healthcare Management Services), Ms. Bachman was the Laboratory Support Group Supervisor at East Tennessee Children's Hospital and served as the liaison to physician's offices and the hospital. She has also served as the Laboratory Supervisor for the VA Outpatient Clinic, overseeing the entire laboratory operation, including quality assurance, regulatory Compliance , and patient education. 3. clia Compliance Manual Table of Contents Chapter One: Introduction to clia . clia Basics Certificate Levels State/Regional Agencies with Contact Information Duel States Glossary Additional clia Information by State Chapter Two: Personnel Requirements General Qualifications Director Information Director Responsibilities General Personnel Responsibilities Director Questions and Answers Chapter Three: Applying for your clia Certificate clia Instructions and Forms COLA Instructions and Forms Chapter Four: Developing Your Compliance Notebooks Developing Your Laboratory Personnel Records (Yellow Tab).

7 Requirements Personnel Forms Training Forms Evaluation Forms Developing Your Procedure Manual (Red Tab). Procedure Manual Requirements and Forms Developing Your Quality Assessment Notebook (White Tab). Quality Assessment Requirements and Forms Special QA Requirements for COLA. VIDAS Method Validation and Quality Control Notebook (Green Tab). Method Basics clia Requirements QC Policies Forms Proficiency Testing Notebook (Pink Tab). Selecting and Enrolling in a Proficiency Testing Program Performing Proficiency Testing Instructions and Forms for Corrective Actions Chapter Five: Preparing for Your Laboratory Inspection Preparation and Recommendations Common Deficiencies Checklists Additional Section: Installation Records 4. FRONT/BACK. NOTICE/ABOUT THE AUTHORS. ALL OTHER PAGES FRONT ONLY. 5. Introduction to clia . What is clia ? clia is the Clinical Laboratory Improvement Amendments of 1988. It is an amendment to the original Clinical Laboratory Improvement Act of 1967.

8 The purpose of clia 88 is to provide site- neutral quality (accuracy, reliability, and timeliness) of patient testing results. clia 67 covered only Medicare, Medicaid, and interstate commerce; clia '88 has a much broader scope. The Health Care Financing Administration (HCFA), now known as the Center for Medicare and Medicaid Services (CMS) is responsible for implementation of clia , including laboratory registration, fee collection, surveys, surveyor training and guidelines, enforcement, PT provider approval, accrediting organizations and exempt states. CMS is responsible for developing the criteria for test waivers. The Food and Drug Administration now has the responsibility for test categorization (previously done by the Centers for Disease Control and Prevention). The original final clia regulations were published on February 28, 1992, with thirteen corrections added later. Most enforcement surveys began in 1994. The final, final clia regulations were published on January 24, 2003, with an effective date of April 24, 2003.

9 The goal was to make the regulations more user friendly by organizing them in a more logical sequence, following the specimen from collection through reporting. Very few actual changes were incorporated; notably, the requirement for moderate complexity laboratories to perform validation studies for new test systems was added after April 24, 2003. The new regulations refer to "waived" and "non-waived" tests. Moderate complexity tests now must meet the same quality control and quality assessment regulations as high complexity tests. NOTE: State and local regulations, as well as those of other healthcare accrediting agencies (such as the Joint Commission on American Healthcare Organizations), may supercede clia if they are more stringent. Who is governed by clia ? clia covers any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, of impairment of, or assessment of health.

10 (See the CMS website.) Forensic testing is not included, nor is imaging (ultrasound, mammography, etc.) or skin testing (TB, Candida, ). Breath tests (alcohol, H. pylori) are currently not covered but are under consideration for inclusion. Tests performed in the home by the patient are not covered. Tests done in the home by healthcare workers to instruct the patient in doing the test ( , glucose monitoring) are not covered. Other tests done in the home by healthcare workers ( , blood gases) are covered. Certificates What are the complexity levels? 1. Certificate of Waiver 2. Provider-Performed Microscopic Procedures Certificate 3. Certificate of Compliance or Accreditation for Moderate or High Complexity Testing 1. Certificate of Waiver Laboratories performing waived tests must: a. Have a Certificate b. Pay biannual fees 1. c. Follow the manufacturer's instructions Laboratories with a Certificate of Waiver may perform waived tests only. This certificate does not include any microscopies.