QUALITY CONTROL

External Quality Control Programs

LabCorp’s primary concern in sample processing is always the quality of data produced.  As part of this effort, the laboratory participates in the following quality control programs:

National Laboratory Certification Program (under SAMHSA)--(four surveys per year)

The College of American Pathologists (CAP)

          Urine Drug Confirmation Program (four surveys per year)

          Urine Toxicology Program (three surveys per year)

          Blood Alcohol Program (three surveys per year)

          Forensic Toxicology Confirmation

New York State Department of Health (four surveys per year)

Pennsylvania Department of Health (four surveys per year)

Florida (one survey per year) 

External proficiency program results provide a tool by which to gauge the laboratory’s performance.  Proficiency results are tracked by program, by drug, and by drug across the various programs.  Involvement with proficiency programs often leads to procedural improvements and new method development.  

In addition, LabCorp routinely participates in quality control programs sponsored by its clients and will comply with a similar program requested by your company.  All quality control information is confidential.  Upon request, LabCorp will provide access to a review officer designated by your organization, at our site, to review internal quality control documentation or for auditing sample results and general laboratory performance.  External quality control/proficiency program data will be shared except where restricted by the certifying agency.

Internal Quality Control Programs

LabCorp’s Quality Control program includes the preparation and/or certification of reference materials used in performing sample analyses in accordance with the LabCorp Standard Operating Procedures (SOP’s).  The Labcorp QC department maintains the records of preparation and certification of these materials.  In addition, LabCorp staff gathers and analyzes data that are used to determine the accuracy and reliability of laboratory results.  LabCorp QC staff monitors several areas of laboratory performance on a regular basis and reports trends or “out of acceptable limits” results to the appropriate laboratory management.  The QC Department maintains the laboratory’s permanent records of performance monitoring.

Calibrators and controls for initial test and confirmation procedures are either purchased from commercial manufacturers or prepared by the LabCorp QC Department.  These materials are prepared by fortifying certified negative urine with certified drug standard solutions.  Validation of these materials is by parallel testing with a previously approved control pool.  All urine-based reference material used in the laboratory must be prepared in urine that has been certified as “drug-free” and free of substances that may cause interference in the drug assays.  Urine must be negative by all test procedures and contain no interfering substances to be certified.  Once certified, the urine may be used to prepare calibrators, controls, and certified negative urine pools.