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: a) Based on review of laboratory policies and procedures, laboratory records, and interview with the laboratory director (LD), the laboratory failed to perform bi-annual method accuracy verifications twice a year for Mohs micrographic surgery testing from 09/28/2023 through 02/15/2025 in the subspecialty of histopathology. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Proficiency Testing (Mohs lab)", which stated, under "Policy of Proficiency Enrollment:", "Since there is no proficiency survey program available for Mohs surgery the lab will twice a year send slides to a Mohs College colleague and/or WCP laboratories to be evaluated and examined." 2. Review of laboratory records revealed the laboratory had failed to send slides out for comparative testing twice a year. Date of testing: Date of review by colleague: First half of 2023 09/28/2023 Second half of 2023 02/15/2025 First half of 2024 02/15/2025 Second half of 2024 02/15/2025 3. Interview with the LD on 02/18/2025, at 12:32 pm, confirmed the laboratory failed to perform bi-annual method accuracy verifications twice a year for Mohs micrographic surgery testing from 09/28/2023 through 02/15/2025 in the subspecialty of histopathology. ______________________________________ b) Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory director (LD), the laboratory failed to perform bi-annual method accuracy verifications twice a year for frozen section biopsy testing in the subspecialty of histopathology from the beginning of 2023 through the date of survey, 02/18/2025, affecting eight patient test results. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Proficiency Testing (Mohs lab)", which stated, under "Policy of Proficiency Enrollment:", "Since there is 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 -- no proficiency survey program available for Mohs surgery the lab will twice a year send slides to a Mohs College colleague and/or WCP laboratories to be evaluated and examined ....In addition, when cases are sent for external consultation the comparison of the diagnosis in the consultation report is compared with the diagnosis from the Mohs surgeon and a recommendation is made." 2. Review of laboratory records revealed no documentation of bi-annual method accuracy for eight histopathology frozen section biopsies tested from the beginning of 2023 through the date of survey, 02/18/2025. Year: Date: Biopsy #: 2023 01/27/2023 1 2023 05/24/2023 2 2023 05/25 /2023 3 2023 08/29/2023 4 2023 08/29/2023 5 2023 08/29/2023 6 2024 01/26/2024 1 2024 11/06/2024 2 3. Interview with the LD on 02/18/2025, at 12:32 pm, confirmed the laboratory failed to perform bi-annual method accuracy verifications twice a year for frozen section biopsy testing from the beginning of 2023 through the date of survey, 02/18/2025, affecting eight patient test results. -- 2 of 2 --