The first inspection was conducted by the College of American Pathologists, http://www.cap.org, which conducts unannounced inspections every two years in order to ensure clinical laboratory operations maintain a high level of quality service.
"This type of inspection underscores the critical role that laboratory data plays in assisting physicians in diagnosis and treatment of their patients," said Lee Asnin, Laboratory Manager at SEARHC Mt. Edgecumbe Hospital.
The SEARHC Mt. Edgecumbe Hospital clinical laboratory is one of more than 6,000 CAP-accredited laboratories nationwide. The CAP Laboratory Accreditation Program began in the early 1960s and it is recognized by the federal government as being equal to or more stringent than the government's own inspection program.
During the accreditation process, inspectors examine the laboratory's records and quality control of procedures for the preceding two years. Inspectors also examine the entire staff's qualifications, the laboratory's equipment, facilities, safety program and record, as well as the overall management of the laboratory.
The second inspection was conducted by the State of Alaska Department of Health and Social Services in order to validate the CAP inspection. This second inspection not only validated the CAP findings, but it also showed the SEARHC Mt. Edgecumbe Hospital clinical laboratory meets the current standards for the federal Clinical Laboratory Improvement Amendments, http://www.cms.hhs.gov/CLIA.
The federal Centers for Medicare and Medicaid Services regulates all laboratory testing (except research) performed on humans in the United States through the Clinical Laboratory Improvement Amendments. In total, CLIA covers approximately 189,000 laboratory entities and the objective of the CLIA program is to ensure quality laboratory testing. All clinical laboratories must be properly CLIA-certified to receive Medicare or Medicaid payments, although CLIA has no direct Medicare or Medicaid program responsibilities.