Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records, the lack of records for 2022, 2023, and 2024; and interview with laboratory personnel, it was determined the laboratory failed to verify the accuracy of Mohs procedures and Biopsy pathology reporting. Findings included: 1. Personnel Report, CLIA (CMS209, 4/08/25) specified Testing Personnel in Histopathology, and affirmed by the laboratory person (4/11/25 at 11:00 AM), as follows : Testing Person-1 Biopsy, Mohs Testing Person-2 Biopsy Testing Person-3 Biopsy, Mohs Testing Person-4 Biopsy 2. MOHS a. Laboratory records selected for this CLIA survey documented Mohs procedures performed in 2022- 2024, as follows: Date Mohs Case # Mohs Surgeon -------------------------------------------------- 4/12/22 CM22-7232 Testing Person-1 8/15/22 CM22-7468 " " 11/28/22 CM22-7691 " " 1/10 /23 CM23-7765 Testing Person-1 2/07/23 CM23-7832 " " 7/11/23 CM23-8128 " " 10 /23/23 DN23-0015 Testing Person-3 12/18/23 DN23-0051 " " 1/23/24 CM24-8508 Testing Person-1 7/16/24 CM24-8755 " " 10/07/24 CM24-8877 " " 11/21/24 CM24- 8965 " " 8/26/24 DN24-0259 Testing Person-3 12/30/24 DN24-0375 " " b. The laboratory failed to have records verifying the accuracy of Mohs procedures performed by Testing Person-1 in 2022, 2023, and 2024. c. The laboratory failed to have records verifying the accuracy of Mohs procedures performed by Testing Person- 3 in 2023 and 2024. 3. BIOPSY PATHOLOGY a. Laboratory records selected from 2022-2024 for this CLIA survey documented Biopsy Pathology reported by Testing Personnel, as follows: i. Testing Person-3 Date Biopsy ID Biopsy Slide # 10/23/23 K8603 DNK23-8603 10/23/23 K8604 DNK23-8604 4/08/24 K8849 NK24-8849 11/04 /24 K9240 DNK24-9240 ii. Testing Person-4 Date Biopsy ID Biopsy Slide # 1/31/22 D7606 PBD22-7606 9/22/22 D9119 PBD22-9119 1/06/23 D9749 D23-9749 10/30/23 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D1640 PBD23-1640 (continued) iii. Testing Person-SK Date Biopsy ID Biopsy Slide # . 1/10/23 K8544 K23-8544 2/27/23 K8558 K23-8558 b. The laboratory failed to have records verifying the accuracy of Mohs procedures performed by Testing Person- 3 in 2023 and 2024. c. The laboratory failed to have records verifying the accuracy of Mohs procedures performed by Testing Person-4 in 2022 and 2023. d. The laboratory failed to have records verifying the accuracy of Mohs procedures performed by Testing Person-SK in 2023. 4. The laboratory person affirmed (4/11/25 at 7:30pm) the aforementioned findings and lack of records verifying accuracy of testing. 5. Testing Personnel performed and reported 6,500 Histopathology tests annually, including Mohs procedures and Biopsy pathologies. The reliability and quality of testing in Histopathology could not be assured during this CLIA survey. . D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation of the new Cryostat (Dakewe 6250, serial number 07030849) for sectioning skin cancer specimens, review of Mohs records, the lack of temperature records, and interview with laboratory personnel, it was determined the laboratory failed to monitor and document the Cryostat's temperature. Findings included: 1. The laboratory had charts documenting the acceptable range of temperatures for the Cryostat ( -20 to -30 C). 2. The Mohs Log documented procedures were performed on 7/16/24, but the Cryostat temperature records could not be found for the timeframe 3 /01/24 to 9/06/24. 3. The laboratory person affirmed (4/11/25 at 5:00pm) the aforementioned findings and that Mohs procedures were performed every month. 5. The laboratory sectioned 541 cases each month (CMS116, CLIA Application, 4/08 /25). 4. The quality and reliability of the Cryostat to maintain proper temperature from March through August 2024, could not be assured during this CLIA survey. . D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on review of Mohs records, the lack of H & E Stain QC records, and interview with a laboratory person, it was determined that the laboratory failed to document the quality of Stains after 2/29/24. Findings included: 1. Dates of procedures randomly selected from the Mohs Log were, as follows: 7/16/24, 8/26/24, 10/07/24, 11/21/24, 12 /30/24 2/17/25, 2/27/25 2. The laboratory failed to have records documenting Stain -- 2 of 3 -- Quality after 2/29/24. 3. The laboratory person affirmed (4/11/25 at 7:00pm) the aforementioned findings and was unable to find the missing records. 4. The quality and reliability of the Stains could not be assured during this CLIA survey. The laboratory processed and stained 541 cases each month (CMS116, CLIA Application, 4/08/25). . . -- 3 of 3 --