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.
Data 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 qualification of personnel who provide oversight on laboratory 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-surveys and audits as well as performing surveys of peer organizations.
All Michigan Medicine Department of Pathology Laboratories is registered with The Centers for Medicare & Medicaid Services (CMS), under the U.S. govt. Department of Health and Human Services (HHS) and have certificates of compliance, accreditation or waiver. Additionally, Michigan Medicine Laboratories are accredited by the following agencies with deeming authority from HHS:
The compliance manager functions as external liaison to CMS and Accrediting organizations ensuring proper regulatory and accreditation application for new labs, timely application renewal for existing labs and administration of the Department of Pathologies document control system as well as internal liaison regarding Pathology’s integration with other departmental compliance entities within the Michigan Medicine system