West Hills Dermatology Group

Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) (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 the laboratory's quality assessment policy, procedure and documentation, five (5) Mycology patient records and interview with the office manager (OM), it was determined that the laboratory failed to correct errors upon its occurrence. The findings include: 1. Based on the surveyor's review of the quality assessment policy, procedure, and documentation, it was determined that the laboratory was performing daily checks but was limited solely to Dermatopathology records. 2. Based on the surveyor's review of 5 patient records for potassium hydroxide (KOH) tests in Mycology, covering the period from September 12, 2022, to June 21, 2024, one out of 5 was found to have discrepancies in records and reports. Specifically, for Patient RM, who was examined on March 8, 2023, the patient log book indicated a negative result, while the final report in the patient's chart recorded a positive result. 3. On February 26, 2025, at approximately 11:50 a.m., the OM affirmed by interview that the discrepancy noted in statement #2 were neither recognized when they occurred nor detected during the daily quality assessment checks. At the time of the survey, there were no records of

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 ten (10) randomly selected patient biopsy (Mohs) slides, patient final testing reports (electronic medical records (EMR), slide labeling, and interview with the laboratory personnel, it was determined that from 01/10/2019 through 02/04 /2021 for 1 out of 10 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: 1. Review of patient slide Ref. Biopsy # DD20-6528, Location (L Ventral Forearm 02/13/20) and the unique identifier Location (proximal hand) transcribed in the patent's final testing report (EMR) did not match. 2. On 03/16/2021 11:30 a. m. (survey date), the laboratory personnel affirmed that the unique identifier (Location) found on the biopsy(Mohs) slide did not match the unique identifier (Location) in the patient's final testing report (EMR). 3. Based on the laboratory's annual test volume declaration (03/16/2021) the laboratory performed 320 patient biopsies (Mohs) annually. 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 --