QUALITY ASSURANCE PLAN (QAP)

LabCorp’s strong commitment to provide unexcelled forensic quality data has been established at the highest levels of management within the organization.  LabCorp’s QA provides an independent oversight of each function, including the QC Section.

The QA functions provide an overall system for verifying and maintaining the desired product of our service: Forensic Quality Data.  Compliance to Federal and State regulations, contract and SOP mandates are assured through means of independent auditing.  These audits include review of data files and computer-accessed information, as well as observations of laboratory procedures.  Results of all QA audits and ancillary functions are fully documented and provided to laboratory management.  The reports include the corrective action taken.  The reports reinforce that the operational areas are functioning under control.  Our corporate commitment to quality extends into all areas and the independent, watchful care provided by the QA process benefits our customers.

Listed below is an overview of some functions of the Quality Assurance audits:

The System Audit

The system audit is a physical walk through the facility that is performed on a monthly basis.  This audit encompasses SOP compliance, safety compliance, good laboratory practice, and the effectiveness of training programs.  The quality assurance staff visit the laboratory areas on a monthly basis to provide timely support and assistance with corrective action implementation.

The Regulatory Compliance Review

The QA manager maintains a close working relationship with regulatory agency representatives and conducts periodic reviews based on State, Federal, Environmental, Safety, and Labor requirements.

The Training Audit

LabCorp’s QA provides start-up training associated with the introduction of a new process, material, regulatory requirement, or hazard. 

The Submission of Blind Specimens

Double blind specimens are submitted to the laboratory to challenge all aspects of the testing process: turn-around time, chain-of custody, initial and confirmatory testing, validation of analytical procedures, security and reporting of results.  The submission of blind specimens verifies standard procedures, performance and compliance throughout the drug testing process. 

The Assessment of Quality Control Materials

The QA department evaluates initial test and confirmatory test data from QC certified calibrators, controls, and assays evaluation studies.

The Accessioning and Initial Test Audit

The QA department performs monthly data audits in the Accessioning and Initial test areas.  These monthly audits consist of a review of chain-of-custody documents, open and blind controls, verification systems, computer generated documentation, and certifying scientist reviews.

The Confirmation Test Audit

The quarterly confirmation test audit consists of a review of chain-of-custody documents, SOP compliance, technical data (GC/MS and GC), instrument calibrations, control data, specimen data and certifying scientist reviews.

The Security Audit

The QA staff is responsible for auditing to assure that employee security badges are appropriately activated and deactivated.  The security system is monitored to verify that restricted entry procedures are followed.

The Review of Litigation Packages

A random selection of litigation packages are reviewed.  The data are evaluated to verify forensic acceptability.

Medical Waste Audit

Medical Waste Manifest are renewed weekly for regulatory compliance.  The rate of waste production is tracked, with the ultimate goal being waste minimization.