Thomas 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 March 9, 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. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory policy and procedure manual, a review of the submitted CMS-209 form listing the testing personnel (TP) of the laboratory, the lack of documentation of initial training and competency assessment for one of two histotechnicians that perform gross analysis of dermatopathology specimens, and an interview with TP#1 and TP#2, the laboratory failed to ensure that policies and procedures were established and followed for competency assessments to ensure that the personnel could produce accurate and reliable results. Findings include: 1. There was no record of initial training and competency assessment for one of two histotechnicians performing gross analysis of tissue prior to performing patient testing. The personnel was hired in July, 2025. There was no record of competency assessment until January, 2026. The testing personnel (TP) #2 listed on the CMS-209 form confirmed that patient testing had been performed by the TP#2 between the hire date and the date of the January competency assessment. 2. A review of the laboratory policy and procedure manual revealed that there was no director approved policy and procedure for the training and competency assessment of testing personnel. 3. The 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 -- findings were confirmed during an interview with testing personnel TP#1 and TP#2 conducted on March 9, 2026 at approximately 10:00 AM. According to the submitted CMS-116 form, the laboratory performs 6,032 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 the lack of 2024 and 2025 records of twice per year verification of accuracy for gross analysis and for the slide interpretation of dermatopathology specimens, a review of the laboratory procedure entitled, "Quality Assessment Policy and Procedure", and an interview with the testing personal (TP)#1 from the submitted CMS-209 form, the laboratory failed to ensure that twice per year verification of accuracy was performed and documented during 2024 for two of two (TP#1 and TP#4) histotechnicians, and during 2025 for two of two (TP#1 and TP#2) histotechnicians that performed gross analysis of dermatopathology tissues, and the laboratory failed to ensure that twice per year verification of accuracy was performed and documented during 2024 and 2025 for one of one testing personnel performing slide interpretation of dermatopathology specimens. Findings include: 1. The laboratory failed to follow their director approved policy and procedure entitled, "Quality Assessment Policy and Procedure", which stated that the lab manager was responsible for ensuring that the "grossers undergo biannual verification of all appropriate tasks and procedures." 2. There were no records of twice per year verification of accuracy for 2024 for either TP#1 or TP#4, and no records of twice per year verification of accuracy for 2025 for either TP#1 and TP#2 performing the gross analysis of dermatopathology tissue. TP#4 left the laboratory in November, 2024. 3. There were no records of twice per year verification of accuracy for TP#3 for slide interpretation of dermatopathology specimens. 4. The findings were confirmed during an interview with TP#1 conducted on March 9, 2026 at approximately 10:30 AM. According to the submitted CMS-116 form, the laboratory performs 6,032 histopathology tests annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 policy and procedure entitled "Quality Assessment Policy and Procedure," a lack of laboratory records during 2024 and 2025 for one of one testing personnel of twice per year verification of accuracy in the performance of slide interpretation of dermatopathology specimens, and an interview with TP#1 listed on the CMS-209 form, the laboratory failed to establish a policy and procedure for the performance of twice per year verification of accuracy for testing personnel (TP) performing slide interpretation of dermatopathology specimens. -- 2 of 4 -- Findings include: 1. A review of the laboratory policy and procedure entitled "Quality Assessment Policy and Procedure" revealed that the laboratory failed to establish a policy and procedure for twice per year verification of accuracy that included personnel performing slide interpretation of dermatopathology specimens. The policy stated that the lab manager was responsible for ensuring that the "grossers undergo biannual verification of all appropriate tasks and procedures." There was no indication that the personnel performing the slide interpretation of dermatopathology specimens must also participate in twice per year verification of accuracy each year. 2. There were no records for twice per year verification of accuracy for one of one testing personnel (TP#3) performing slide interpretation of dermatopathology specimens. 3. The findings were confirmed during an interview with the TP#1 on March 9, 2026 at approximately According to the submitted CMS-116 form, the laboratory performs 6,032 histopathology tests annually. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and 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 the lack of quality assessment records for 22 of 22 months between May, 2024 and February, 2026, a review of the laboratory policy entitled, "Quality Assessment Policy and Procedure," and a telephone conversation with Testing Personnel (TP)#1 on March 12, 2026, the director failed to ensure that the established quality assessment program was maintained to ensure the quality of the laboratory testing performed. Findings include: 1. There were no records of quality assessment review for 22 of 22 months between the dates of May 2024 and February 2026 available for review at the time of the survey. 2. A review of the laboratory policy entitled, "Quality Assessment Policy and Procedure" revealed that laboratory failed to establish a time frame in the policy and procedure to indicate how frequently the laboratory was to perform quality assessment activities. 3. The findings were confirmed during a telephone conversation with TP#1 on March 12, 2026 at approximately 1:45 PM. According to the submitted CMS-116 form, the laboratory performs 6,032 histopathology tests annually. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on a review of the laboratory personnel records, and an interview with Testing Personnel (TP)#1 and TP#2 listed on the CMS-209 form, the director failed to ensure that one of two histotechnicians had the appropriate education and either experience or training to accurately perform and report results of gross analysis of dermatopathology tissue specimens, and the director failed to ensure that initial -- 3 of 4 -- training and competency assessment was performed and documented for one of two histotechnicians prior to performing testing and reporting results of gross analysis for dermatopathology tissue specimens. Findings include: 1. A review of the laboratory personnel testing personnel records revealed that there were no records of the highest level of education for TP#2 to verify that the TP#2 was qualified to perform gross analysis of dermatopathology specimens. 2. A review of the laboratory personnel testing personnel records revealed that there were no records of initial training and competency for TP#2 listed on the CMS-209 form until January, 2026. The testing personnel was hired in July, 2025. 3. The TP#1 and TP#2 confirmed that the records for the highest level of education were not available for review for TP#2. TP#1 and TP#2 confirmed that patient testing had been performed by TP#2 prior to January, 2026 during an interview conducted on March 9, 2026 at approximately 9:30 AM. According to the submitted CMS-116 form, the laboratory performs 6,032 histopathology tests annually. -- 4 of 4 --