Summary:
Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of 2024-2026 laboratory records for Mohs procedures and interview with Medical Assistants 1, 2, and 3; it was revealed that the identity of the Testing Person/Mohs Surgeon was not recorded on the Mohs maps and the Mohs Surgery Procedure Notes. Findings included: 1. The laboratory reported 3 testing persons performing Mohs procedures [CMS209, Laboratory Personnel (CLIA), 4/15/26]. 2. Twenty-five out of 25 Mohs maps reviewed failed to record which Mohs Surgeon performed the procedure and approved the maps drawn with assistance from Medical Assistants. 3. Laboratory records from 2024-2026 titled, "Mohs Procedure Note", failed to identify the Mohs Surgeon for 7 out of 25 cases, as follows: Date Mohs Case # -------------------------------------------- 1/25/24 24-018 6/15/24 24-194 8/29/24 24-291 12/07/24 24-419 4/19/25 25-113 6/17/25 25-197 9/11/25 25-284 4. Medical /Laboratory assistants - 1, 2, and 3 affirmed (5/12/26 at 1:30 PM) the aforementioned findings in which the identify of the Testing Person was not recorded. . D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems 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 -- identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of laboratory records for Mohs procedures and interview with Medical/Laboratory Assistants and the Laboratory Director, it was revealed the laboratory failed to establish a written procedure and ongoing process to monitor records for accuracy, identify discrepancies and errors, determine root cause, and apply