Gerald N Bock Md

Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on the surveyor's review of five (5) Mohs patient records and an interview with the medical assistant (MA), two (2) out of five (5) Mohs patient records were discrepant in their patient log, assessment notes with mapping, and final report. The findings include: 1. Based on the review of 5 Mohs patient records, 2 out of 5 records were discrepant across the patient log sheet, assessment notes with mapping, and final report. a) Patient 22-145: i. Accesion number on log sheet was marked 22-011, but assessment notes with mapping and final report recorded 22-145. ii. Patient log recorded six stages, assessment notes with mapping indicated five stages, final report recorded four stages, and slides retrieved were only until stage three. b) Patient 22- 070: i. Accesion number on log sheet was marked 22-070 but final report recorded 22- 670. ii. Patient log recorded three stages, while assessment notes with mapping and final report recorded four stages, and slides retrieved were only until stage three. 2. The MA affirmed during the interview on October 9, 2024, at approximately 3:00 p. m. that the discrepancy described in number 1 (a, b) above was recorded erroneously. Further investigation is needed to be performed. No

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of patient pathology slides, patient medical record (MR), slide labeling, and interview with the laboratory personnel on 12/01/2021 at 10:30 a.m., it was determined that from 02/05/2020 through 09/10/2021 for one (1) out of seven (7) random patient testing records reviewed, the laboratory failed to follow written policies and procedures for specimen collection, labeling and biopsy reports for each biopsy specimen. The findings included: a. Review of patient pathology biopsy slides found that the unique slide identifier (patient name) found on the slides 20-009 I,A, I, B did not match the unique slide identifier (patient name) found in the patient's medical record. b. On 12/01/2021 11:30 a.m. (survey date), the laboratory personnel confirmed that the unique identifier (patient name) found on the pathology biopsy slides did not match the final patient medical record. c. Based on the laboratory's annual test volume declaration (11/16/2021) the laboratory performed 1,630 histopathology patients' testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --