Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site initial CLIA certification survey conducted at your facility on June 23, 2026. The findings and conclusions of any investigation by the Division of Healthcare Purchasing and Compliance 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 four patients tested between the dates of January 5, 2026 and May 11, 2026, and an interview with the Mohs technician, the laboratory failed to ensure positive identification of three of the four patient specimen records reviewed from the time of collection of the specimen through completion of testing and reporting results. Findings include: 1. A random patient audit of four patients tested between the dates of January 5, 2026 and May 11, 2026 revealed that the laboratory failed to ensure positive identification for three of four patient specimen records reviewed as follows: A. A review of the patient record, identification number (ID) MM0000000466 (seven zeros), tested on January 5, 2026 revealed that the patient ID number was incorrect on two of the five slide labels. The ID number for the slide designated as 1-2(B) was MM000000466 (six zeros). The ID number for the slides designated as 3-4(A) and 3-4(C) were each MM00000000466 (eight zeros). B. A review of the patient record, identification number (ID) MM0000000464 (seven Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- zeros), tested on February 2, 2026 revealed that the patient ID number was incorrect on the Mohs log, the Mohs map, and on two of two slide labels. The ID number on the patient log was MM00000000046 (nine zeros) and dropped the final number "4." The ID number on the Mohs map was MM000000046 (eight zeros) and dropped the final number "4". The ID number on two of two slide labels was MM0000000046 (nine zeros) and dropped the final number "4". C. A review of the patient record, identification number (ID) MM0000000982 (seven zeros), tested on May 11, 2026 revealed that the patient ID number was incorrect on the Mohs log, and on two of two slides. The ID number on the Mohs log was MM0000000 (seven zeros) and dropped the last three digits "982." The ID number on two of two slides was MM000000982 (six zeros). 2. The findings were confirmed during an interview with the Mohs technician on June 23, 2026 at approximately 11:15 AM. According to the CMS-116 form submitted on June 23, 2026, the laboratory performs 60 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 director approved procedure manual, a random patient audit of four patients tested between the dates of January 5, 2026 and May 11, 2026, and an interview with the Mohs technician, the laboratory failed to establish and follow written policies and procedures to monitor, assess and correct problems with three of four patient specimen identification errors when they occurred. Findings include: 1. There was no written director approved policy and procedure for quality assessment to monitor, assess and correct problems with specimen identification when they occurred. 2. A random patient audit of four patients tested between the dates of January 5, 2026 and May 11, 2026 revealed that the laboratory failed to ensure positive identification for three of four patient specimen records reviewed as follows: A. A review of the patient record, identification number (ID) MM0000000466 (seven zeros), tested on January 5, 2026 revealed that the patient ID number was incorrect on two of the five slide labels. The ID number for the slide designated as 1-2(B) was MM000000466 (six zeros). The ID number for the slides designated as 3-4(A) and 3-4 (C) were each MM00000000466 (eight zeros). B. A review of the patient record, identification number (ID) MM0000000464 (seven zeros), tested on February 2, 2026 revealed that the patient ID number was incorrect on the Mohs log, the Mohs map, and on two of two slide labels. The ID number on the patient log was MM00000000046 (nine zeros) and dropped the final number "4." The ID number on the Mohs map was MM000000046 (eight zeros) and dropped the final number "4". The ID number on two of two slide labels was MM0000000046 (nine zeros) and dropped the final number "4". C. A review of the patient record, identification number (ID) MM0000000982 (seven zeros), tested on May 11, 2026 revealed that the patient ID number was incorrect on the Mohs log, and on two of two slides. The ID number on the Mohs log was MM0000000 (seven zeros) and dropped the last three digits "982." The ID number on two of two slides was MM000000982 (six zeros). 3. The -- 2 of 4 -- findings were confirmed during an interview with the Mohs technician on June 23, 2026 at approximately 11:15 AM. According to the CMS-116 form submitted on June 23, 2026, the laboratory performs 60 histopathology tests annually. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of