Regulatory

Clinical Laboratory Improvement Amendments (CLIA)

The CLIA - Clinical Laboratory Improvement Amendment Consists of a Series of Amendments (42 CFR 493) for Establishing Laboratory Standards

The Clinical Laboratory Act (or CLIA) regulates the safety and effectiveness of clinical laboratory diagnostic testing. Clinical laboratories that use Web-based software solutions to comply with regulations in the Clinical Laboratory Act can save vast amounts of time and revenue.

CLIA or the Clinical Laboratory Improvement Amendments (42 CFR Part 493) are those regulations that were established in 1988 for the regulation and quality assurance of human specimens within clinical laboratory environments.

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Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid

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White Paper: Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid White Paper: FDA Inspections of Clinical Investigators: Are You Ready? White Paper: Software Automation in the Blood and Biologics Industry
FAQ: Compliance with FDA's Good Tissue Practices
Data Sheet: MasterControl Audit
Industry Brief: Simplify CAPA in 7 Steps

The MasterControl quality management suite for clinical laboratory improvement amendments is an integrated, configurable, and easy-to-use software solution designed to facilitate compliance with the CLIA - Clinical Laboratory Improvement Amendments and related FDA regulations. Here's how MasterControl can help laboratories meet the requirements of the major CLIA requirements and at the same time increase efficiency and keep compliance costs down:

CLIA Requirements

MasterControl CLIA Features

( CLIA Section 493.120 )

Requires establishment and maintenance of written policies and procedures for clinical laboratory improvement amendments that implement and monitor quality systems for all phases of the total testing process as well as general laboratory systems.

MasterControl Documents™ automates routing, escalation, approval, and delivery of SOPs, policies, and other documentation. Provides a centralized Web-based repository that's secure, but at the same time accessible to all authorized users. MasterControl provides automatic revision control and CLIA facility to ensure that only the current version of an SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports.

( CLIA Section 493.1445 )

Requires the lab director to make sure that policies and procedures are established for monitoring competency of employees who conduct testing and identify the needs for remedial training or continuing education to improve their skills.

MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams. Clinical laboratory improvement amendments allow sequencing of training courses, so after a prerequisite is completed, the next course is automatically launched. Provides group sign-off feature for verifying training of large groups of employees.

( CLIA Section 493.1251 )

Requires the lab director to approve, date, and sign any changes in procedure.

MasterControl Change Control™ streamlines the entire change control procedure for faster turnaround. It offers a best-practice CLIA form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change is likely to require regulatory filing. Customizable reports provide real-time status of change control tasks and the entire quality system.

( CLIA Section 493.1233 )

The clinical laboratory improvement amendments must have a system in place to ensure that it documents all complaints and problems reported. The lab must investigate the complaints when appropriate.

MasterControl Customer Complaints™ streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process of clinical laboratory improvement amendments is incorporated in a pre-configured, multi-page form that starts with processing of a complaint, moving to internal investigation, and culminating with issue resolution.

( CLIA Section 493.1282 )

Corrective action policies and procedures must be available and followed as necessary to maintain the laboratory's operation for testing patient specimens in a manner that ensures accurate and reliable patient test results and reports.

MasterControl CAPA™ integrates the corrective and preventive action process with other quality processes. Provides best-practice "8D" process that guides the quality team through every step of CAPA. A CAPA form can be launched directly from another form (i.e., a nonconformance report). CLIA system automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle.

( CLIA Section 493.1239 )

Requires laboratories to establish procedures for ongoing mechanism to monitor, assess, and when necessary, correct problems identified in the general laboratory system and to perform accurate clinical laboratory improvement amendments.

One of the best ways to evaluate the state of a laboratory is through quality audits. MasterControl Audit™ automates, streamlines, and effectively manages the audit process. The CLIA system by MasterControl provides advanced tracking capability, from scheduling and planning to execution and completion. Offers best practice forms for tracking basic audit information and audit findings. Automates scheduling of all recurring audit-related activities and provides analytics and reporting capability for increased management visability.