Clinical Pathology

Home Laboratory Services Online Handbook Compliance & Accreditation Licensure/Accreditation Pathology Home Contact Information
  1. Home Laboratory Services
  2. Compliance & Accreditation

Compliance & Accreditation

The clinical laboratory industry is highly regulated for one primary reason: The information laboratories generate guide clinicians in the appropriate diagnosis, intervention, and management of the healthcare of the most important customer, the patient. 

Test results must be accurate, reliable, and actionable to ensure a safe and beneficial outcome for the patient. To ensure this, laboratories are required to adhere to quality standards as prescribed by Federal and State law as well as Accrediting Organizations (AO) with deemed authority to act on behalf of the government. The standards include qualifications of laboratory personnel who provide oversight on clinical operations to the personnel performing the testing, to the processes used in testing. 

Laboratories are surveyed on a regular basis by a number of agencies to ensure compliance with laws and standards regarding laboratory testing. In addition to these external surveys, laboratories also conduct internal self-inspections and audits as well as performing surveys of peer organizations.

All Michigan Medicine Department of Pathology Laboratories are registered with The Centers for Medicare & Medicaid Services (CMS) and have CLIA certificates of Compliance, Accreditation, Provider Performed Microscopy, or Waiver. Additionally, Michigan Medicine laboratories are accredited by the following agencies with deemed-status authority from CMS:

  • College of American Pathologists (CAP)
  • Joint Commission (JC)
  • American Association of Blood Banks (AABB)
  • Foundation for the Accreditation of Cellular Therapy (FACT)
  • American Society for Histocompatibility and Immunogenetics (ASHI)
  • National Association of Medical Examiners (NAME)

The compliance manager functions as an external liaison to CMS and laboratory accrediting organizations ensuring proper regulatory and accreditation standards are adhered to. They also serve as an internal liaison regarding Pathology’s integration with other departmental compliance entities within the Michigan Medicine health system.