Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed at Integrated Dermatology of Northshore, CLIA ID 19D2299994, on September 25, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following policies: a) Complaint Investigations to include how to address, document, and handle complaints or problems reported to the laboratory b) Twice a year verification for the accuracy of Histopathology testing, to include, but not limited to frequency of performance and