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 standard operating procedure (SOP) review, direct observation, and interview with technical consultant, SOP for labeling of slides is not being followed. Findings include: 1. SOP manual states that slides will be labeled with patient name, medical record number (MRN), date of surgery, site of surgery, Mohs case number, stage number, and piece number. 2. In three of eight histology tests reviewed, the slides had pre-printed labels on them. These labels did not include the MRN of the patient. All other labeling information required in the SOP was present on the label. The laboratory performs approximately 1600 histology tests annually. 3. In an interview on 7/14/2021 at approximately 12:30 pm, the technical consultant confirmed that the laboratory had changed from handwriting the labels on the slides to preprinting labels. The preprinted labels did not include the MRN of the patient. 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 --