Clinical Pathology

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 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:

  • College of American Pathologists (CAP)
  • The Joint Commission (TJC)
  • 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.

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)

NCRC

UH and Mott

East Ann Arbor Surgery Center

West Ann Arbor Health Center

Northville Health Center

Kellogg Eye Center

Brighton Center for Specialty Care

Domino's Farms MEND

American Association of Blood Banks (AABB)

UH and Mott Transfusion Medicine Laboratory

American Society for Histocompatibility and Immunogenetics (ASHI)

NCRC Histocompatibility Laboratory 

Foundation for the Accreditation of Cellular Therapy (FACT)

Blood and Bone Marrow Transplant Program

The Joint Commission

Joint Commission Accredited Organizations

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).

Other Licensure

 

National Provider Identifier (NPI)

https://npiregistry.cms.hhs.gov/search

UM Hospital and Health Centers #1003878539

UM Medical School #1508890468
New York

NCRC #8910

CFF Burkholderia cepacia Lab #8252

 California

UH and Mott Lab ID #CDS00800320

NCRC Lab ID# CDS00800323

Clinical Laboratory Improvement Amendments (CLIA) Licenses

 

Certificates of Accreditation (CoA)

https://qcor.cms.gov/main.jsp

NCRC COA

UH and Mott COA

East Ann Arbor Surgery Center COA

West Ann Arbor Health Center COA

Northville Health Center COA

Kellogg Eye Center COA

Brighton Center for Specialty Care COA

Domino's Farms MEND COA

Certificates of Waiver (CoW)

https://qcor.cms.gov/main.jsp

Briarwood #5 Health Associates COW

Briarwood #9 Radiology COW

Brighton Center for Specialty Care COW

Domino Farms Comprehensive Wound Clinic COW

Domino Farms Preventative Cardiology COW

Howell Health Center COW

Kellogg Eye Center COW

Kellogg Eye Center - Grand Blanc COW

Livonia Center for Specialty Care COW

MEND COW

Northville Health Center COW

Physical Med and Rehab, Burlington Building COW

Rachel Upjohn COW

RAHS Dailey Elementary COW

RAHS Ypsilantic Wellness Center COW

UH and Mott Point of Care CoW

UM Orthotics & Prosthetics COW

UMHS Center for Reproductive Studies COW

UMHS Student Free Clinic COW

West Ann Arbor Health Center COW

Provider-Performed Microscopy (PPM)

https://qcor.cms.gov/main.jsp

Briarwood #2 Women, Children, & Young Adults PPM

Briarwood #3 Medical Group PPM

Briarwood #10 Family Practice PPM

Brighton Health Center PPM

Brighton Specialty Care PPM

Canton Health Center PPM

Chelsea Family Practice PPM

Chelsea Professional Building PPM

Dexter Health Center PPM

Domino Farms Family Medicine PPM

East Ann Arbor Health Center PPM

Livonia Health Center PPM

Livonia Center for Specialty Care PPM

Northville Health Center PPM

Saline Health Center PPM

UH and Mott PPM

West Ann Arbor PPM

West Shore Urology PPM

Ypsilanti Health Center PPM