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 Clinical 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:
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.
Licenses and Certificates
Accreditation
NOTE: CAP certifications may appear expired; however, the posted date does not reflect an expiration, but the date that is required for a re-inspection. The Department of Pathology and Clinical Laboratories follow all CAP standards and are in good standing until notified otherwise. Updated certificates will be published as soon as they become available.
| College of American Pathologists (CAP) | |
| American Association of Blood Banks (AABB) | |
| American Society for Histocompatibility and Immunogenetics (ASHI) | |
| Foundation for the Accreditation of Cellular Therapy (FACT) | |
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The Joint Commission |
Organization ID# 7457 |
Certificates, Licensures, Permits, and Registrations
NOTE: As of January 2019, the State of Michigan office of Licensing and Regulatory Affairs will no longer be processing laboratory director changes for Certificate of Accreditation labs. These changes must be completed by the laboratory's Accrediting Organization. When demographic changes are requested, new certificates are not issued and information may appear out of date. CLIA certificate information can be verified using the CMS lab lookup website, S&C QCOR (cms.gov).
ON THE COVER
Breast team reviewing a patient's slide. (From left to right) Ghassan Allo, Fellow; Laura Walters, Clinical Lecturer; Celina Kleer, Professor. See Article |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
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ON THE COVER
Autopsy Technician draws blood while working in the Wayne County morgue. See Article |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
ON THE COVER
Dr. Sriram Venneti, MD, PhD and Postdoctoral Fellow, Chan Chung, PhD investigate pediatric brain cancer. See Article |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
ON THE COVER
Director of the Neuropathology Fellowship, Dr. Sandra Camelo-Piragua serves on the Patient and Family Advisory Council. |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
ON THE COVER
Residents Ashley Bradt (left) and William Perry work at a multi-headed scope in our new facility. |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
ON THE COVER
Dr. Kristine Konopka (right) instructing residents while using a multi-headed microscope. |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
ON THE COVER
Patient specimens poised for COVID-19 PCR testing. |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
ON THE COVER
Dr. Pantanowitz demonstrates using machine learning in analyzing slides. |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
ON THE COVER
(Left to Right) Drs. Angela Wu, Laura Lamps, and Maria Westerhoff. |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
ON THE COVER
Illustration representing the various machines and processing used within our labs. |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
ON THE COVER
Rendering of the D. Dan and Betty Khn Health Care Pavilion. Credit: HOK |
newsletter
INSIDE PATHOLOGYAbout Our NewsletterInside Pathology is an newsletter published by the Chairman's Office to bring news and updates from inside the department's research and to become familiar with those leading it. It is our hope that those who read it will enjoy hearing about those new and familiar, and perhaps help in furthering our research. CONTENTS
|
MLabs, established in 1985, functions as a portal to provide pathologists, hospitals. and other reference laboratories access to the faculty, staff and laboratories of the University of Michigan Health System’s Department of Pathology. MLabs is a recognized leader for advanced molecular diagnostic testing, helpful consultants and exceptional customer service.