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The Clinical Testing, Regulatory Compliance, and Technical Support (CTRCTS) department at the South Bend Medical Foundation (SBMF) monitors the quality of lab test performance and services the quality assurance needs of the entire organization.
The South Bend Medical Foundation maintains a comprehensive quality management plan (QMP) that objectively and systematically monitors and evaluates the ongoing quality of the total testing process (pre-analytic, analytic and post-analytic) for ensuring and improving quality of lab services adn patient safety for patients and health care providers to whom we provide our service. The elements of this plan have been developed using the College of American Pathologist Laboratory Accreditation Program Standards, CLIA requirements, the New York State Department of Health Clinical Laboratory Standards of Practice, and the Clinical and Laboratory Standard Insitutes (CLSI) Quality System Essentials (QSE's) guidelines.
The laboratory monitors and evaluates the quality and appropriateness of patient care, the effectiveness of policies and procedures; identifies and corrects problems, assures the accurate, reliable and prompt reporting of test results, assures the adequacy and competency of the staff, and pursues opportunities to improve patient care.
Implementation of the QMP is monitored through defined quality indicators reported through the Quality Management Report. Indicators are in place to monitor all phases of testing, pre-analytic, analytic, and post analytic, as well as indicators to monitor operational performance as well. Examples include specimen acceptability, specimen identification, monitoring of proficiency testing performance, turn-around-times, revised reports, and customer complaints to name a few.
We continually evaluate our quality indicators to help us make improvements to our system, which ultimately enhances value to our clients.
SBMF is committed to providing high quality services. We maintain compliance with federal, state and local laws and regulations. The South Bend Medical Foundation is accredited by the College of American Pathologist Laboratory Accreditation Program, AABB, FDA, and New York. To ensure compliance, an extensive internal auditing program is in place that includes identification of sub-optimal performance and then follow up through corrective action.
We also provide technical support to our clients in many ways. We can assist clients with licensure and accreditation, provide mock inspections, assist with interpretation of regulations, as well as provide services for thermometer and pipette calibrations.
