Quality assurance (QA) and quality control (QC) are an integral part of LabCorp’s daily operation.
LabCorp utilizes both internal and external systems to monitor the accuracy and precision of testing performed in its facilities.
LabCorp’s QA and QC programs are overseen and administered by the National Office of Quality and Science. Standardized QA programs are implemented and monitored by QA managers located in each of the operating divisions throughout the country.
Quality Assurance (QA) Plans
Each laboratory facility follows a written QA plan that specifies a systematic process for monitoring and evaluating pre-analytical, analytical, post-analytical, and service aspects of testing quality and problem resolution. Laboratory test quality and service are monitored and evaluated through routine collection of information and periodic performance assessments.
QA committees meet regularly at each lab site to review performance monitors and resolve any potential issues. The committee also evaluates the effectiveness of remedial actions taken. The effectiveness of the overall plan and the appropriateness of each aspect of care are reviewed on an annual basis.
Internal Quality Control (QC)
LabCorp’s national quality control (QC) program ensures the accuracy and precision of patient results reported by our laboratories. Control samples with known analyte concentrations are routinely included with patient samples submitted for testing. Our computerized control algorithms, based on the widely accepted Westgard rules, alert the testing analyst of significant analytical anomalies as they occur. More than 2.5 million QC values are generated for evaluation each month by LabCorp’s facilities nationwide. This highly responsive, computer-assisted quality control process helps detect and correct potentially erroneous results before they are released to clients.
In order to compare testing quality throughout LabCorp, a national QC database containing quantitative QC results has been developed. QC is evaluated on a real-time basis to identify any significant exceptions. This system ensures that consistently high quality results are generated by every LabCorp facility.
LabCorp has an extensive internal proficiency testing program in which specimens are referred quarterly to each laboratory, and results are graded and distributed to the laboratory directors for evaluation and follow-up. This internal proficiency program serves to test LabCorp’s analytical and post-analytical phases of service including order entry, accessioning systems, accuracy, precision of its testing protocols, technologist/technician performance, and quality assurance reporting checks. This program serves to supplement the external proficiency programs supplied by laboratory accrediting agencies.
LabCorp voluntarily participates in more than 20 externally administered proficiency testing programs, including the College of American Pathologists (CAP). Consistently acceptable performance on these surveys is a prerequisite for continued licensure and certification. Significant findings from the internal and external proficiency programs are reviewed at the national level. The internal and external proficiency programs supplement other QA procedures and provide LabCorp’s management with a monitor that can be used to review technical and service performance.
Specimen Integrity System
LabCorp’s Specimen Integrity System (SIS) is a front-end operations system designed to reduce or eliminate common errors introduced through manual procedures. This system incorporates both a Front End System (FES) and a Storage and Retrieval System (SRS).
The component is designed to integrate laboratory processes for accessioning, electronic requisition processing (ERP), double key entry verification, electronic requisition processing (ERP) verification, report data entry, and billing data entry. FES features include:
- Inventory-to-test-ordered validation
- Double key test codes and other selected fields
- Test-specific and account-specific flags
- Worksheet generation after verification
- LCLS billing data entry functionality
The component guides specimen storage, splitting, tracking, and the reference of specimens through the LabCorp network.