How to Obtain CLIA Certification

Introduction

It is necessary to have a CLIA certification before you accept any specimens for testing in a diagnostic laboratory. The CLIA (Clinical Laboratory Improvement Act) regulates laboratory testing by ensuring laboratories are in compliance with the Medicare and Medicaid (CMS) guidelines. When opening a laboratory, it is imperative to run your operation according to these standards which will ensure quality testing.

In this post we will review what is necessary to obtain a CLIA license, and what is required to pass your inspection.

Certain aspects of the process are subject to your specific circumstances depending on what type of laboratory you are opening. In this guide we will focus mainly on the independent clinical laboratory model. There are numerous specific details that are required to get your CLIA certification that are easily overlooked. We offer consulting services if you want to guarantee your lab is up to CLIA standards and will pass inspection in a reasonable timeframe.

Requirements:

• Policies and Procedures
• Personnel Qualifications
• Quality Assurance (QA) and Quality Control (QC) Plan
• Equipment Validation and Preventative Maintenance

Policies and Procedures

Policies and procedures are a written set of guidelines and practices that will outline a roadmap for compliance, quality management, training personnel, and resolving testing issues. They serve as the infrastructure to maintain your laboratory’s rules and regulations. Not having a precise set of Policies and Procedures can lead to inconsistent testing and compliance violations.

Quality Assurance & Quality Control Plan

QA and QC is written into procedures to ensure thoroughness by providing a means for analysis of the processes involved in your laboratory testing. This is a preventative and precautionary method that CLIA requires to ensure that work produced in the laboratory is of the highest quality and the results are produced with consistency.

The QA program must:

1. Assess the effectiveness of the lab’s policies and procedures.
2. Identify and correct issues.
3. Assure the accurate, reliable, and prompt reporting of test results.
4. Assure the adequacy and competency of the staff.
5. Document all QA activities

CLIA’s 10 Standards for Quality Assurance:

1. Patient Test Management – A system for monitoring and evaluating patient Testing Procedures.
2. Quality Control – An ongoing process of evaluating your system’s quality and implementing solutions and preventative measures to meet quality standards.
3. Proficiency Testing – The ability to take corrective action when faced with errors.
4. Test Comparisons – Comparing of the results of different test methods
5. Relate Results to Clinical Data – The ability to recognize test results as abnormal when compared to ranges of patients in the same demographic.
6. Personnel – Training to ensure competence and assess qualifications.
7. Communications – Education, observation, and corrective action regarding communication to protect patient information.
8. Complaints – A system to document and investigate complaints.
9. Staff review – Staff reviews to assess and document QA to implement changes to issues that arise.
10. Records – Maintained documentation of QA activities available to the HHS (Department of Human Health and Human Services).

Lab Personnel Requirements

To get your CLIA certification your personnel must have proper qualifications. Individuals can serve in one or multiple of the required positions if they meet the qualifications for the specific role.

Designated Medical Director:

The laboratory director oversees CLIA requirements to ensure they are being met. They may take on the responsibilities of each required position as long as they are qualified to do so and can adequately perform the duties of each role. They are responsible for the overall operation and administration of the laboratory. Must be accessible to provide onsite, telephone, or electronic communication, and when delegating duties, it must be done in writing.

Delegated personnel:

• Technical Supervisor
• Technical Consultant
• General Supervisor
• Clinical Consultant
• Testing Personnel

Equipment Validation and Preventative Maintenance

Equipment validation involves a series of tests you run through your testing equipment to validate that the specifications listed by the manufacturer are being met. This is important because it determines errors present in the results of each piece of equipment to prevent misinterpretation of a test due to machine malfunctions.
Preventative Maintenance is a part of the QA & QC plan to regularly maintain equipment to mitigate the possibility unexpected malfunctions.

Laboratory Demographics

This includes your address, specimen volume, personnel, and personnel qualifications. This is required to complete an application with CLIA.

Passing Inspection

Once you submit your application, CLIA will review it and in normal conditions will send someone out between 30-60 days of submission. However, in some areas of the country they may take longer, because of the number of labs. Due to recent COVID-19 circumstances this time has increased.
The inspector will assess your laboratory, making sure your policies and procedures are being followed, and are up to standard.