Thomas Dermatology - 2871 St Rose Pkwy

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 February 24, 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. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) records for the 2019 microbiology and the 2019 mycology test events two and three, the API 2020 and 2021 microbiology and mycology test events one, two and three, and an interview with personnel numbers four and five listed on the CMS-209 form, the laboratory failed to ensure that the proficiency testing specimens were rotated among all of the providers who performed the testing for the potassium hydroxide (KOH) preparations and for the dermatophyte test media (DTM). Findings include 1. The attestation statements for the 2019 API proficiency test events two and three, and the 2020 and 2021 API proficiency test events one, two and three for microbiology and mycology testing of KOH preparations and DTMs were signed by the laboratory director as the testing personnel. 2. During an interview on February 24, 2022 at approximately 10: 00 AM with personnel numbers four and five listed on the CMS-209 form, it was confirmed that only testing personnel number one listed on the CMS-209 form had performed the proficiency testing specimens. It was further confirmed that patient testing for DTM and KOH tests was performed by testing personnel number two 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 -- listed on the CMS-209 form and that patient testing for KOH tests was performed by testing personnel numbers three, eight, nine, ten and eleven listed on the CMS-209 form. The laboratory performs approximately 140 Mycology tests annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the 2020 American Proficiency Institute (API) Mycology test event one records, a review of the participant summary for the 2020 API mycology test event one, and an interview with personnel numbers four and five listed on the CMS-209 form, the laboratory failed to review the participant summary to evaluate the laboratory's performance for the ungraded result obtained on the API specimen number DER-01. Findings include: 1. A review of the 2020 API Mycology test event one report revealed that there was no documentation of a review of the participant summary for the ungraded result for specimen number DER-01. The laboratory reported the result of positive (dermatophytes present). 2. A review of the participant summary obtained at the time of the survey revealed that the result that the laboratory reported on the event was consistent with 26 of 53 laboratories that participated in the API 2020 Mycology test event one. 3. During an interview with personnel numbers four and five listed on the CMS-209 form on February 24, 2022 at approximately 10: 30 AM, it was confirmed that the participant summary had not been reviewed for the ungraded result. The laboratory performs approximately 140 Mycology tests annually. -- 2 of 2 --

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 July 17, 2019. 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 patient Mohs testing from 9/05/17 through 6/06/19 and an interview with the laboratory manager, the laboratory failed to follow the director approved policy to ensure positive identification identification from the time the patient's specimen was received through the completion of the test and the reporting of the results. Findings include: 1. The laboratory failed to ensure the patient identification was ensured from the time the specimen was collected through the completion of the test. 2. A random audit of patient Mohs testing from 9/05/17 through 6/06/19 found one of ten patient Mohs slides to not have the account number on the slide as established in the director approved policy and procedure manual. 3. A patient who had a Mohs procedure performed on 5/06/19 revealed that there were 2 of 16 patient slides that had no unique patient account number indicated on the slides. This was confirmed by the laboratory manager on July 17, 2019 at approximately 10: 30 AM. The laboratory performs approximately 5038 patient Histopathology tests 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 2 -- 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 American Proficiency Institute (API) proficiency testing results for testing years 2017, 2018 and 2019 and an interview with the laboratory manager, the laboratory failed to, at least twice annually, verify the accuracy of patient testing that the laboratory performs. Findings include: 1. The laboratory failed to at least twice annually during the testing year 2017, verify the accuracy of patient testing for KOH preparation. 2. A review of the API proficiency testing results for KOH preparation for testing year 2017, revealed a score of 50% for the first event, a score of 0% for the second event and a score of 100% for the third event. There was no additional evaluation for accuracy for the 2017 testing year for KOH. This was confirmed by the laboratory manager on July 17, 2017 at approximately 10:00 AM. The laboratory performs approximately 246 Microbiology patient tests annually. -- 2 of 2 --