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CLIA Certified
CLIA Certified

CLIA (Clinical Laboratory Improvement Amendments)

On November 1, 2014, Mass Histology Service, Inc. became a CLIA-certified lab. This certification allows Mass Histo to perform human diagnostic testing in-house.

The following list describes what measures Mass Histo takes in order to ensure that all of our procedures conform to these standards:

• The Laboratory Director is George Holsten, MD
• The Laboratory Manager is James E. Staruk, HT(ASCP)
• The License number is 5380

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 251,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

• For additional information about a particular laboratory, contact the appropriate State Agency or Regional Office CLIA contact (refer to State Agency or Regional Office CLIA link found on the left-hand navigation pane);
• Information about what is CMS’ authority regarding Laboratory Developed Tests (LDTs) and how does it differ from FDA’s authority is found in the downloads section in the file called "LDT and CLIA FAQs";
• CMS Blog - FDA & CMS Form Task Force on LDT Quality Requirements;
• Information on research testing and CLIA is found in the file called "Research Testing and CLIA";
• Information about direct access testing (DAT) and the CLIA regulations is included in the Direct Access Testing download;
• OIG reports relating to CLIA;
• Guidance for Coordination of CLIA Activities Among CMS Central Office, CMS Regional Offices, State Agencies (including State with Licensure Requirements), Accreditation Organizations and States with CMS Approved State Laboratory Programs is contained in the Partners in Laboratory Oversight download;
• Quality control (QC) highlights from the regulations published in the Federal Register on January 24, 2003 are listed under the QC Highlights download;
• Micro sample pipetting information for laboratories;
• Information on alternative (non-traditional) laboratory is contained in the Special Alert download;
• Identifying Best Practices in Laboratory Medicine - a Battelle Project for the Centers for Disease Control and Prevention (CDC); and
• FDA Safety Tip for laboratories on how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices.