Signature Plastic Surgery And Dermatology

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 November 8, 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 audit of seven patients who had Mohs surgery between the dates of November 11, 2021 and July 22, 2023 and an interview with the practice manager and the medical assistant, revealed that the laboratory failed to ensure that positive identification of patient specimens was maintained from the time of collection through completion of testing and reporting of results. Findings include: 1. A random audit of Mohs patients tested between the dates of November 20, 2021 and July 22, 2023 revealed that the Mohs case number on the final operative report for one of seven patients reviewed did not match the case number on the Mohs log, and on the Mohs map. The Mohs case number was also excluded from the Mohs slide. 2. A review of the patient identified on the Mohs log, and Mohs map by the case number RL22-024, revealed that the case number included on the Mohs final operative report was recorded as RL22-023. 3. A review of the patient identified on the Mohs log, and Mohs map by the case number RL22-024, revealed that the case number was not included on the Mohs slide. 4. The findings were confirmed during an interview with 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 -- the practice manager and the medical assistant conducted on November 8, 2023 at approximately 3:45 PM. The laboratory performs approximately 20 histopathology tests 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 lack of laboratory records, and an interview with the practice manager and the medical assistant, the laboratory failed to verify the accuracy of the Mohs procedure at least twice annually. Findings include: 1. There were no records for twice per year verification of accuracy for the Mohs testing available for review for the years of 2022 and 2023. 2. The findings were confirmed during an interview with the practice manager and the medical assistant on November 8, 2023 at approximately 2:30 PM. The laboratory performs approximately 20 histopathology tests annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual and an interview with the practice manager and the medical assistant, the laboratory failed to have an established policy and procedure for the performance of twice per year verification of accuracy for the Mohs testing. Findings include: 1. The laboratory failed to have an established policy and procedure for the performance of twice per year verification of accuracy that specified how the laboratory would verify the accuracy of the Mohs testing at least twice annually, as required. 2. The laboratory procedure entitled, "Proficiency Testing" available for review did not address proficiency testing or twice per year verification of accuracy for those analytes not included in subpart I of the CLIA regulations. It addressed training and competency assessment for the laboratory personnel. 3. The finding was confirmed during an interview with the practice manager and the medical assistant conducted on November 8, 2023 at approximately 2:15 PM. The laboratory performs approximately 20 histopathology tests annually. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a random patient audit of seven patients who had Mohs surgery between the dates of November 11, 2021 and July 22, 2023 and an interview with the practice manager and the medical assistant, revealed that the laboratory failed to ensure that the cryostat temperatures and maintenance were documented on each day of patient testing. Findings include: 1. A random audit of seven patients who had Mohs surgery between the dates of November 11, 2021 and July 22, 2023 revealed that the laboratory failed to ensure that the cryostat temperatures and maintenance were documented on three of seven days of patient testing. The cryostat temperatures and maintenance were not documented on November 20, 2021, March 19, 2022, and January 7, 2023. 2. The findings were confirmed during an interview with the practice manager and the medical assistant conducted on November 8, 2023 at approximately 3:30 PM. The laboratory performs approximately 20 histopathology tests annually. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random audit of seven patients who had Mohs surgery between the dates of November 11, 2021 and July 22, 2023 and an interview with the practice manager and the medical assistant, revealed that the laboratory failed to ensure that the stain quality was documented on each day of patient testing. Findings include: 1. A random audit of seven patients who had Mohs surgery between the dates of November 11, 2021 and July 22, 2023 revealed that the laboratory failed to ensure that the stain quality was documented on two of seven days of patient testing. The stain quality was not documented on March 19, 2022 and January 7, 2023. 2. The findings were confirmed during an interview with the practice manager and the medical assistant conducted on November 8, 2023 at approximately 3:30 PM. The laboratory performs approximately 20 histopathology tests 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 audit of seven Mohs patients tested between the dates of November 20, 2021 and July 22, 2023, a review of the laboratory quality assessment checklists between the dates of November, 2021 and July, 2023, and an interview with the practice manager and the medical assistant, the director failed to ensure that the established quality assessment program detected and corrected errors in quality when they occurred. Findings include: 1. A random audit of seven Mohs patients between the dates of November 20, 2021 and July 22, 2023 revealed that the laboratory failed -- 3 of 4 -- to detect and correct inconsistencies in the patient labeling and records for one patient tested on January 7, 2023. 2. A random audit of seven Mohs patients between the dates of November 20, 2021 and July 22, 2023 revealed that the laboratory failed to detect and correct the failure to record cryostat temperatures and maintenance, and microscope maintenance on three of seven dates of testing. The cryostat temperatures and maintenance and microscope maintenance were not documented on November 20, 2021, March 19, 2022, and January 7, 2023. 3. A random audit of seven Mohs patients between the dates of November 20, 2021 and July 22, 2023 revealed that the laboratory failed to detect and correct the failure to document the stain quality control on two dates. There was no documentation of the stain quality control on March 19, 2022 and January 7, 2023. 4. A review of the laboratory quality assessment checklists between the dates of November, 2021 and July, 2023 revealed that the quality assessment audit performed by the laboratory on each day of Mohs testing (with the exception of the form completed for the January 7, 2023 Mohs date) recorded that there was no documentation of twice per year verification of accuracy for one of one Mohs surgeons. 5. There was no documentation of

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 of August 31, 2021. 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 three patients tested between the dates of January 15, 2021 and March 26, 2021, a review of the director approved policy and procedure entitled "Slide Labeling," the director approved policy entitled, "Internal Quarterly Quality Assessment," and an interview with the office manager, and the medical assistant, the laboratory failed to ensure that the established policies and procedures were followed to maintain the positive identification and consistent documentation of the patient information for the specimen from the time of collection of the specimen through the reporting of the test results. Findings include: 1. A random patient audit between the dates of January 15, 2021 and March 26, 2021 revealed that there was no unique patient identification number that corresponded to the patient biopsy reports recorded on the Mohs log, and that the specimen identification information was not consistent through the pre-analytical, analytical and post-analytical phases of testing for three of three patient records reviewed. 2. A review of the patient record identified on the Mohs log as case number 0002, performed on January 15, 2021, revealed that 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 -- the Mohs case number was not written on the patient slide labels, and no identification number that corresponded to the biopsy case number, S20-008068, was included on the Mohs log. The Mohs slide labels included the patient name, the date of service, the stage of the procedure, designated with the Roman numerals I and II, and the site of the Mohs procedure. One of two slide labels included a number designated as ACNC# S21-000098. The second of two slide labels included the letters ACNC#, but no number was written on the slide. The reference biopsy number written on the Mohs map, S21-000098, did not match the biopsy case number of S20-008068. 3. A review of the patient record identified on the Mohs log as case number 0007, performed on February 12, 2021, revealed that the biopsy case number, PH21-000007, was not included on the Mohs log. The biopsy case number was included on the Mohs map and the slide labels. 4. A review of the patient record identified on the Mohs log as case number 0012, performed on March 26, 2021, revealed that the Mohs case number on the log was not consistent in the final Mohs operative report, and that the Mohs log did not include the biopsy case number, PH21-000146, which was written on the Mohs map, and written on the Mohs slide labels. On the Mohs final operative report, the Mohs case number was identified as 0013. 5. The director approved policy entitled, "Internal Quarterly Quality Assessment Audit," in the section entitled, "Analytic" stated, "Slides unique ID correspond to Pathology report." 6. The director approved policy entitled, "Slide Labeling" stated in step 2, "Slides are to be labeled with: Mohs Log Accession Number, Patient Name, Number of Stages (will be marked with Roman Numeral; stage I, II, III, etc.), Quadrant or number of tissue/chunks per stage will be marked with numeral; # "1", "2", "3", etc., Number of slides per case will be marked level "A", for first cuts, level 'B' for second, and so on." 7. The findings were confirmed during an interview with the office manger and the medical assistant conducted on August 31, 2021 at approximately 12:30 PM. The laboratory performs approximately 50 histopathology tests 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 review of the director approved policy entitled, "Internal Quarterly Quality Assessment Audit," a review of the completed Quarterly Patient Quality Assurance Checklists for the dates of January 15, 2021 and March 26, 2021, a review of the completed "Quarterly Quality Assurance Checklist," and an interview with the office manager and medical assistant, the director failed to ensure that the established policy and procedure was consistent with the procedures used in the laboratory, and that the quality assessment activities were adequate to detect and correct discrepancies in the specimen identity in the pre-analytic, analytic, and post-analytic phases of Mohs testing. Findings include: 1. A review of the completed Quarterly Patient Quality Assurance Checklist for the dates of January 15, 2021 and March 26, 2021 revealed that the quality assurance review failed to detect and document