Summary:
Summary Statement of Deficiencies 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 Mohs test procedure, review of patient reports and interview with the facility personnel, the laboratory failed to follow the procedure for test reporting for 2 out of 4 reports reviewed. Findings include: 1. Review of the established Mohs test procedure states, "The accession number (Mohs Case Number) will be referenced in EMA, in the patient's chart along with the office note." 2. Two out of four test reports reviewed (DV606-2022 and DV254-2024) in the Electronic Health Record, EMA, failed to include the accession number. 3. Interview with the facility personnel on August 22, 2024 at 11:40 AM confirmed the laboratory failed to follow the procedure for test reporting in EMA. 4. The laboratory results approximately 1,500 histopathology patient tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --