Pictured are some of the staff from the Laboratory at Memorial Hospital, which had no deficiencies in a recent survey. Shown, from left to right, are: Shafiq Hasan, Christina Bartel, Tiffany Caldwell, and Stephanie Rogers, Laboratory Manager. Staff not pictured: Trevor McKee, Jordan Tibbetts, Kris Roney, Sara Schuerch, Kathryn Alanes, and Jackie Estelle.
A Laboratory Survey conducted on May 23 showed no deficiencies for the Laboratory at Memorial Hospital in Abilene. Most labs usually get at least a couple deficiencies, and zero is difficult to achieve.
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the United States through the Clinical Laboratory Improvement Amendments (CLIA). The CLIA program is a Federal regulatory oversight program, the intent of which is to ensure the quality of all laboratory testing on humans in the United States for health purposes.
“This is great news, and a huge congratulations goes to Stephanie Rogers and her laboratory staff for all the tremendous work they have put in over the past three months,” said Harold Courtois, Memorial Health System CEO.
If a laboratory performs moderate and/or high complexity tests (which Memorial Health System Laboratory does both), it is subject to the CLIA quality standards which include: personnel qualifications and responsibilities, proficiency testing (PT), quality control (QC), a recordkeeping system, and quality assurance (QA). These laboratories are inspected biennially. The standards for CLIA for high complexity tests are most stringent in the areas of laboratory director qualifications and quality control. The focus of these assessments, surveys, or inspections is ‘outcomes’. In the case of laboratories, this means whether the laboratory’s test results are accurate, reliable, and timely since most laboratories do not have direct interactions with patients’ outcomes.
Laboratory Inspection: The View From CMS
Judith A. Yost, MA, MT(ASCP)
Division of Laboratories, Centers for Medicare and Medicaid Services, Baltimore, MD