Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and certification is recommended. Standard level deficiencies were cited. D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the patient test reports, Mohs maps, and slides, the laboratory failed to include a stage in Mohs for one of 10 Mohs test reports reviewed. Findings follow. A. Review of 10 randomly selected Mohs cases showed Mohs case ASM25- 058 was missing a STAGE in the visit notes which also served as the patient test report. Review of the visit notes for the Mohs Surgery only documented 1 stage: "STAGE 1: The area was prepped with Hibiclens. A rim of normal appearing skin was marked circumferentially around the lesion. The area was infiltrated with local anesthesia. The tumor was first debulked with a curette to remove clinically apparent tumor. An incision at a 45 degree angle following the standard Mohs approach was done and the specimen was harvested as a microscopic controlled layer. Hemostasis was achieved with electrocautery. The specimen was oriented, mapped and placed in 1 block. Each section was then chromacoded and processed in the Mohs lab using the Mohs protocol and submitted for frozen section utilizing hematoxylin and eosin 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 -- histochemical stains. Frozen section analysis showed: No residual tumor seen. Histology: There were no malignant cells seen in the sections examined. Depth of Invasion: tumor not visualized. Perineural Invasion: absent. Scar tissue absent." B. Review of the Mohs map showed there were 2 stages: stage I showed basal cell carcinoma nodular, stage II was clear. C. Review of the case slides showed a total of five slides labeled for stage I slides A, B, C, and stage II slides A and B. D. Interview with the supervisor on June 11, 2025 at 1145 hours in the office confirmed the patient note was incorrect and added they would correct the surgery notes. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the Mohs test report and interview, the laboratory failed to include the address of the facility on the Mohs map for ten of ten cases reviewed. Findings follow. A. Review of the Mohs maps from 11/11/2024 - 04/23/2025 showed no address of the facility. The following reports were reviewed as listed by date of service and case number: Date of Service Case # 1. 11/11/2024 ASM24-020 2. 11/25 /2024 ASM24-032 3. 12/17/2024 ASM24-059 4. 01/15/2025 ASM25-019 5. 02/10 /2025 ASM25-058 6. 02/24/2025 ASM25-080 7. 03/12/2025 ASM25-109 8. 03/26 /2025 ASM25-124 9.04/14/2025 ASM25-150 10. 04/23/2025 ASM25-165 B. Interview with the supervisor on June 11, 2025 at 1130 hours in the office confirmed the address of the facility was not on the Mohs maps. -- 2 of 2 --