Summary:
Summary Statement of Deficiencies D0000 An announced on-site initial survey was performed on 09/04/26. Standard-level deficiencies cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 the laboratory's written procedures, patient reports, and interview with the Mohs manager, the laboratory failed to follow its own written procedure for 1 of 8 patient slides. Findings included: 1. On 09/04/26 at 09:30 am, the Mohs manager confirmed the laboratory performed frozen tissue sectioning using the Leica CM 1850 Cryostat. 2. A review of the laboratory's written procedure titled, "LABELING SLIDES" stated, "In this facility, ALL SLIDES for frozen section specimens will be labeled as follows: 1. Date 2. Name of patient 3. Mohs # 4. Stage # 5. Number of specimen block". 3. A review of patient reports revealed the incorrect visit date on the slides for 1 of 8 patients reviewed. a. Patient 4379125 visit date on the report 04/03/26 - Slide I-1A documented visit date 04/02/26, Slide I-1B documented visit date 04/02 /26 and Slide II-1A documented visit date 04/02/26. 4. Interview on 09/04/26 at 10:00 am with the Mohs manager confirmed the findings above. 5. A review of the laboratory's test volumes revealed an annual test volume of approximately 150 frozen tissue sections annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, review of maintenance records, and interview with the Mohs manager, the laboratory failed to perform a maintenance procedure as required by the manufacturer for 4 of 4 weeks. Findings included: 1. On 09/04/26 at 09:30 am, the Mohs manager confirmed the laboratory performed frozen tissue sectioning using the Leica CM 1850 Cryostat. 2. A review of the Leica CM 1850 Cryostat operator's manual (page 41) section "9.3.1 General maintenance" stated, "Once a week: Apply a drop of oil to the plastic coupling". 3. A random review of the laboratory's maintenance log from 04/01/26 through 04/30/26 revealed no evidence the laboratory followed the manufacturer's weekly maintenance instructions for 4 of 4 weeks. 4. An interview on 09/04/26 at 10:10 am with the Mohs manager confirmed the findings above. 5. A review of the laboratory's test volumes revealed an annual test volume of approximately 150 frozen tissue sections annually. -- 2 of 2 --