Summary:
Summary Statement of Deficiencies D0000 A recertified onsite survey was completed on 08/22/2025. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the review of the laboratory's QA Slide & Microscope Environment Logs from 06/25/2025 to 08/20/2025, patient case list, and confirmed in an interview, the laboratory failed to document stain QC and QC acceptability for 2 of 10 days reviewed. The findings were: 1. Review of QA Slide & Microscope Environment Logs revealed "For each day the laboratory is conducting testing, the histotechnologist on duty will provide a QA slide prior to the initiation of testing. The Lab Director or Mohs Surgeon will validate the QA slide and initial below:" 2. Random review of the laboratory's QA Slide & Microscope Environment Logs from 06/25/2025 to 08/20 /2025 revealed the laboratory failed to document QA Slide & Microscope Environment Log for 2 of 10 days reviewed. 08/13/2025 08/20/2025 3. Review of the patient case list provided by the laboratory on 08/22/2025 at 10:55 am in the break room for the above dates revealed 11 patient cases were performed. 08/13/2025 Accession#: TSCPL2025-131 08/13/2025 Accession#: TSCPL2025-132 08/13/2025 Accession#: TSCPL2025-133 08/13/2025 Accession#: TSCPL2025-134 08/13/2025 Accession#: TSCPL2025-135 08/20/2025 Accession#: TSCPL2025-136 08/20/2025 Accession#: TSCPL2025-137 08/20/2025 Accession#: TSCPL2025-138 08/20/2025 Accession#: TSCPL2025-139 08/20/2025 Accession#: TSCPL2025-140 08/20/2025 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 -- Accession#: TSCPL2025-141 4. An interview on 08/22/2025 at 11:00 am in the break room, the testing personnel#1 (indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center for Medicare and Medicaid Services D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 209, the laboratory's personnel competency records, and confirmed in an interview, the technical supervisor failed to have documentation of testing personnel for initial training records and 6-month competency assessment for 1 of 3 testing personnel. The findings were: 1. Review of CMS 209 form Laboratory Personnel Report (CLIA), signed by the laboratory director on 08/22/2025, revealed the laboratory identified 3 testing personnel performing high complexity tests. 2. Review of the laboratory's personnel competency records revealed the technical supervisor failed to have documentation of initial training records and 6-month competency assessment documentation for 1 of 3 testing personnel performing high complexity testing. Testing personnel #3 Hired date: 11/15 /2024 3. An interview on 08/22/2025 at 10:36 am in the break room, the testing personnel#1 (indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services -- 2 of 2 --