Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review and interview with the laboratory director (LD), the laboratory failed to ensure that the procedure manual was approved, signed, and dated by the LD. Findings: 1. The laboratory began testing on 12/02/2025. The procedure manual in use at the time of the survey was taken from another laboratory which had terminated its CLIA license. 2. Procedure manual review showed that the procedures were signed by two previous LDs who directed at the other laboratory. The procedure manual was not approved (signed and dated) by the current LD. 3. During an interview on 09/09/2026 at 10:13 AM, the LD confirmed that they had not reviewed and approved the current procedure manual before use. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on quality control (QC) and patient log record review and interview with the histotechnician (HT), the laboratory failed to ensure that daily Hematoxylin and Eosin (H&E) stain QC was documented each day of patient testing for one out of 12 days in August 2026. Findings: 1. The laboratory performed H&E staining procedures to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- evaluate histopathology slides for Mohs surgery patients. Daily stain QC for the H&E stain was recorded on the "Control Slide" log (QC log). 2. Patient log record review showed that the laboratory performed Mohs surgery on 12 days between 08/10/2026 and 08/31/2026. 3. A review of daily stain QC logs from 08/10/2026 through 08/31 /2026 showed that the results of the stain QC were not documented on the QC log on one out of 12 days of testing (08/27/2026). 4. A review of patient logs for the same time period showed that there were 16 patients tested on 08/27/2026 ("Mohs case #" 26-1417 through 26-1430). 5. During an interview on 09/09/2026 at 11:00 AM, the HT confirmed that daily stain QC was not consistently documented, recording the quality of the staining characteristics of the H&E stain each day of patient testing. -- 2 of 2 --