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MEDICAL CENTER BOULEVARD

WINSTON-SALEM, NC 27157

QAPI

Tag No.: A0263

Based on review of laboratory procedures, manufacturer's instructions, laboratory equipment maintenance records, review of 2017 H&E (Hematoxylin and Eosin) quality control records, lab personnel files, ad staff interviews, the laboratory failed to develop and implement quality improvements to promote the delivery of quality laboratory services with appropriately processed accurate results for medical interventions. Pursuant to 482.12 Governing Body and 482.22 Medical Staff, facility staff failed to provide oversight of Laboratory Services, in particularly the subspecialty of histopathology. Findings include:

As of March 26, 2018, the laboratory had identified a total of 9,291 histopathology cases requiring review, and reviews had been performed for 1,422 of the cases. During reviews conducted since the February 5-8, 2018 complaint investigation survey, the laboratory had identified an additional 25 cases in which erroneous histopathology test results were reported. The erroneous histopathology test results resulted in unnecessary treatment for 3 patients and a potential delay in treatment for 3 other patients. For the other 19 patients, treatment was not impacted. Case reviews are ongoing.