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 21, 2023. 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 Mohs patients tested between the dates of May 22, 2021 and January 19, 2023, a review of the director approved Quality Assurance Policy, and an interview with the medical assistant, the laboratory failed to ensure that the written policy and procedure was followed to ensure positive identification of the patient specimens was maintained from the time of collection of the specimen through completion of the testing and reporting of results. Findings include: 1. A random patient audit of seven Mohs patients tested between the dates of May 22, 2021 and January 19, 2023 revealed that in the final operative report, the Mohs case number did not match the Mohs case number on the Mohs log, Mohs map, and Mohs slide. The Medical Record Number was incorrectly entered as the Mohs case number on the final operative report for seven of seven patients reviewed. 2. A random patient audit of seven Mohs patients tested between the dates of May 22, 2021 and January 19, 2023 revealed that for the patient tested on May 22, 2021, identified by Mohs case number M21-170, the Mohs case number was not written on the Mohs Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- map. 3. The audit of the Mohs patient tested on May 22, 2021, identified by Mohs case number M21-170, revealed a discrepancy between the Mohs map and the Mohs final operative note regarding the identification of the Mohs surgeon. On the Mohs map, the initials of the Mohs surgeon (JB) did not match the initials for the name of the surgeon (JD) identified in the Mohs final operative report. The Mohs log did not include documentation of the identification of the Mohs surgeon on that date. 4. A review of the Mohs patient logs between the months of May, 2021 and February, 2023 revealed that the laboratory failed to document the Mohs surgeon and the Mohs tech on the logs for 14 of 22 months. 5. The laboratory policy entitled, "Quality Assurance Policy" stated, "A log will also be created by MOHS (sic) Technician so that he/she can maintain an accurate record of speciemens he/she has been processing on each MOHS day. This log will include the following information; Patient (Last, first) name, DOB, Unique Identifier (DOB), MOHS date, & Site being performed. The same information that is presented on the log, will also need to be on the paitent MOHS Map and Slides." 6. The findings were confirmed during an interview with the medical assistant on March 21, 2023 at approximately 11:00 AM. The laboratory performs approximately 235 histopathology procedures annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the 2021 Mohs logs, a review of the Mohs map for a patient tested on May 22, 2021, a review of the 2021 laboratory records for the twice per year verification of accuracy for Mohs testing, and an interview with the medical assistant, the laboratory failed to ensure that twice per year verification of accuracy was performed for each surgeon performing Mohs testing in the laboratory. Findings include: 1. There were no records for twice per year verification of accuracy for a Mohs surgeon identified by the initials "JB"on Mohs logs dated June 24, 2021, July 15, 2021, August 19, 2021, and November 20, 2021 and on the Mohs map for a patient tested on May 22, 2021. 2. The medical assistant confirmed the findings during an interview conducted on March 23, 2023. The laboratory performs approximately 235 histopathology procedures annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a random patient audit of seven Mohs patients tested between the dates of May 22, 2021 and January 19, 2023, a review of the Mohs logs between the months of May, 2021 and February, 2023, a review of the laboratory policy entitled, "Quality Assurance Policy," a review of the laboratory quality assurance records, and an interview with the medical assistant, the director failed to ensure that the established quality assessment program detected and corrected errors when they occurred. -- 2 of 3 -- Findings include: 1. The laboratory policy entitled, "Quality Assurance Policy," in the section entitled, "Post-Analytic" stated, "After MOHS (sic) has been completed for the day, Medical Assistant and Office Manager will review all documents and patient charts to assure that everything is input correctly." It goes on to state, "If any mistakes are found, responsible employee will be counseled & this will be documented in a