CLIA - Clinical Laboratory Improvement Amendments Regulations

Requires establishment and maintenance of written policies and procedures 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 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.

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. Allows 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.

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 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.

The laboratory 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 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.

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). 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.

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. 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.