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Our very own Clinical Testing, Regulatory Compliance and Technical Support (CTRCTS) keeps South Bend Medical Foundation in line, assuring that quality is a priority. This very important department is responsible for the Quality Assurance needs of South Bend Medical Foundation.
A comprehensive Quality Assurance/ Quality Control program is maintained which monitors the overall performance of the total testing process: pre-analytical, analytic and post analytic. This program includes the submission of internal and external blind samples prepared and delivered to each department on a routine basis above and beyond what is required by the College of American Pathologists (CAP). External samples are blind samples that are prepared to appear as real patients and only CTRCTS knows their identity. They are monitored at each phase of the testing process to assess performance.
Internal surveys are developed and sent by the Clinical Testing, Regulatory Compliance and Technical Support Department to verify the comparability of results throughout the clinically appropriate range for tests performed using different methodologies, instruments or testing sites and to ensure the accuracy and reliability of analytic results on patient samples for which there is no external proficiency testing. For analytes where proficiency testing is not available other procedures must be used to validate performance. All Internal Surveys are sent at least semi-annually. We want to ensure that no matter where in the South Bend Medical Foundation your testing is performed, you will have reliable, consistent results.
CTRCTS not only keeps their eye on the testing departments, but monitors our Information Systems, as well.
A system test is performed each working day in the morning, noon and afternoon to detect errors in data transmission, storage and processing. It is also used to verify the integrity of the system after a downtime situation.
There are also systems checks performed annually to ensure that calculations performed on patient data by Cerner, and Rules are functioning properly. These results are compared to manually calculated results in order to identify any discrepancies.
We all know how important compliance with state and federal government regulations is and understand how difficult it is to meet the requirements of accrediting agencies. At SBMF we continually monitor compliance internally and perform surprise inspections on our own departments so they are always at the ready. Not only do we perform inspections routinely for our own laboratory, but upon request, perform mock inspections for our clients.
Other services provided by CTRCTS to our clients are pipette and thermometer calibrations. On an as needed basis with prior notification you can send this equipment to be calibrated.
