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STACS-PM™ helps you to comply with the following accreditation standards:

  • Clinical Laboratory Improvement Amendments (CLIA)
  • College of American Pathologists (CAP)
    • Laboratory Accreditation Program (LAP) and
    • CAP 15189
  • New York State Clinical Laboratory Evaluation Program (CLEP)
  • ISO/IEC 17025
  • CFR Part 11
  • Good Laboratory Practice (GLP)

Our solutions include many sophisticated elements to ensure that laboratories do not deviate from restrictions imposed by these standards—specifically they:

  • Track and control each sample throughout the analysis process. Audit trails are generated for each sample processed.. For each sample, STACS-PM tracks:
    • who performed the work
    • when was the work performed
    • what specific scientific instruments were used
    • what consumables (lot numbers) were used
  • Implement policies and procedures to ensure the protection of confidential information and proprietary rights, including procedures for protecting the electronic storage and transmissions of results.
  • Ensure that purchased supplies, reagents and consumable materials that affect the quality of sample processing are not used until they have been inspected or otherwise verified as complying with SOPs. Records (audit trails) of actions taken to check compliance are also maintained.
  • Track the various batch controls used to ensure quality of the analytical process.

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Download our free white paper “DNA Laboratory Informatics for Personalized Medicine: Opportunities and Challenges”

In this paper, STACS DNA explores emerging opportunities and challenges of personalized medicine for 21st century clinical DNA testing labs, and their implications for bioinformatics.