Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on March 14, 2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a random patient audit of seven patients tested between the dates of December 19, 2019 and February 3, 2022, a review of the director approved policy and procedure for the labeling of patient Mohs slides, a review of the laboratory Mohs log for the dates of December 3, 2020 and February 4, 2021, and an interview with the practice administrator, the laboratory failed to ensure that specimen identification and integrity was maintained from collection of the Mohs specimens through the final reporting of the test results. Findings include: 1. A random patient audit of seven patients tested between the dates of December 19, 2019 and February 3, 2022 revealed that for the patient identified by the date of birth of 1/22/1955, who was tested on September 16, 2021, two of four slides were not labeled with the correct corresponding Mohs surgery stage. A review of the Mohs patient log, and the Mohs map revealed that three stages were required to complete the procedure. According to the Mohs map, there was a total of four slides prepared. For Stage 2, the Mohs map indicated that two slides were prepared. For Stage 3, the Mohs map indicated that one 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 -- slide was prepared. The labels on the slides indicated that there were two slides prepared for Stage 1, identified as I and IB, two slides prepared for Stage 2, identified as II and IIA. There were no slides labeled to corresponded with Stage 3 of the Mohs map and procedure. 2. The director approved procedure for the Mohs processing stated that when labeling slides, the Roman numeral indicates the stage, and the alphabetical designation indicates the slide number for that stage. 3. A review of the Mohs log the between the dates of November, 2019 and February, 2022 revealed that the laboratory failed to enter the date of birth as the unique identifier on the Mohs log for ten of ten patients tested on December 3, 2020, and for 16 of 16 patients tested on February 4, 2021. 4. The findings were confirmed during an interview conducted on March 14, 2022 at approximately 10:15 AM with the practice manager. The laboratory performs approximately 300 Histopathology tests annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the laboratory Mohs log on the dates of December 3, 2020 and February 4, 2021, a review of the laboratory quality assessment records for the months of December, 2020 and February, 2021, and an interview with the practice manager, the laboratory failed to detect and correct the omission of the patient date of birth as the unique patient identifier recorded on the Mohs log. Findings include: 1. The patient date of birth was not included on the Mohs log for ten of ten patients on December 3, 2020, and for 16 of 16 patients tested on February 4, 2021 that underwent Mohs testing. 2. A review of the laboratory quality assessment records for the months of December, 2020 and February, 2021 revealed that the Mohs log review to detect errors or omissions of required information to maintain patient identification was not part of the quality assessment review performed. 3. The findings were confirmed during an interview conducted on March 14, 2022 at approximately 10:45 AM with the practice manager. The laboratory performs approximately 300 Histopathology tests annually. -- 2 of 2 --