Dermatology Associates Of Oak Ridge

Summary Statement of Deficiencies 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 observation of the laboratory, a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CMS-209), the laboratory's policy, personnel records, and staff interview, the laboratory failed to follow its personnel competency policy for two of eight testing personnel (TP) who performed potassium hydroxide (KOH), scabies, and Tzanck smear moderately complex patient testing in 2023 and 2024. The findings included: 1. Observation of the laboratory on 01.13.2025 at 8:30 a.m. revealed KOH reagent, Chlorazol Black E reagent, Mineral Oil, Wright- Giemsa Stain, and a microscope on the counter used for KOH, scabies, and Tzanck smear patient testing. 2. A review of the CMS-209 provided by the laboratory on 01.13.2025 revealed eight testing personnel (TP1-TP8) that performed moderately complex patient testing. 3. A review of the laboratory's "Quality Assessment Plan" section "Personnel Competency" revealed that testing personnel would have competency assessment performed at least annually. 4. A review of laboratory personnel records revealed no documented annual competency assessment for TP1 in 2023 or 2024 and TP2 in 2024, as listed on the CMS-209. 5. An interview with the back laboratory manager on 01.13.2025 at 10:15 a.m. confirmed the above survey findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 observation of the laboratory, review of patient test reports, record request, and interview with the laboratory liaison, the laboratory failed to document hematoxylin and eosin (H&E) stain quality assessment for three of three patients performed on 10.21.2022. The findings include: 1. Observation of the laboratory on 05.08.2023 at approximately 11:00 am revealed processing and staining of tissue for histopathology using hematoxylin and eosin (H&E) stains. 2. Review of randomly selected patient test reports/dates revealed patient histopathology cases reported as follows: 102122-907H--reported on 10.21.2022 102122-908H--reported on 10.21.2022 102122-909H--reported on 10.21.2022 3. Request made to the laboratory liaison on 05.08.2023 at approximately 11 am for H&E stain quality assessment records revealed no documented H&E stain quality assessment on 10.21.2022. 4. Interview with the laboratory liaison on 05.08.2023 at approximately 11 am confirmed the laboratory failed to document H&E stain quality assessment for three of three patients on 10.21.2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 lack of twice a year accuracy verification for peer slide review and interview with the Senior technician, determined the laboratory failed to verify peer slide review accuracy twice a year in 2020 and 2021. The findings include: 1. A lack of twice a year accuracy verification for peer slide review for 2020 and 2021. 2. An interview with the Senior technician at approximately 12:30 pm on February 18, 2022 confirmed only one peer slide review accuracy verification had been documented for 2020 and one peer slide review for 2021. ================================== D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: ================================== Based on review of employee personnel records for 2020 and 2021 and interview with the back lab manager, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for testing personnel number two, three and five listed on the Center for Medicare and Medicaid Services Personnel Report (CMS- 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 -- 209). The findings include: 1) Review of employee personnel records for 2020 and 2021 failed to include documentation of the six required criteria of competency that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills for testing personnel number two, three and five on the CMS-209. 2) An interview with the back lab manager on February 18, 2022 at 12:30 p.m. confirmed testing person number two, three and five listed on the CMS 209 were not evaluated using the six criteria for competency required by CMS for 2020 and 2021. ================================== -- 2 of 2 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: ================================== Based on the observation of a container of instant coffee in laboratory flame cabinet during tour at approximately 8: 30 a.m. July 17, 2018, lack of safety protocol for the laboratory and an interview with the Laboratory Manager and Lead Processor, determined the laboratory lacks safety procedures to ensure personnel protection from biohazardous materials. The findings include: 1. Observation of a container of instant coffee in laboratory flame cabinet at approximately 8:30 a.m. July 17, 2018 during tour. 2. Lack of safety protocol for the laboratory to ensure personnel protection from biohazardous materials. 3. An interview with the Laboratory Manager and Lead Processor at approximately 11:30 a. m. July 17, 2018 confirmed there was a container of instant coffee in laboratory flame cabinet and there is no safety protocol for the laboratory to ensure personnel protection from biohazard materials. =================================== D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities 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 -- specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: =================================== Based on laboratory's maintenance policy for the cryostats, lack of preventive maintenance documentation for cryostat number one and interview with the laboratory manager and lead processor, determined the laboratory failed to have preventive maintenance done on cryostat number one since 2016. The findings include: 1. The Laboratory's maintenance policy for the cryostats state that PM (preventative maintenance) is to be performed every 6 months. 3. Lack of PM documentation since 2016 for cryostat number one. 4. Interview with the laboratory manager and lead processor at approximately 11:30 a.m. July 17, 2018 confirmed there were no PM's performed on cryostat number one for the last two years. ====================================== D6010 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: ================================== Based on observation around 8:30 a. m. July 17, 2018 (during lab tour) of a container of instant coffee stored in flame cabinet, and interview with the laboratory manager and lead processor, determined the laboratory director failed to ensure a procedure that prohibits anything other than chemicals and reagents be stored in the laboratory flame cabinet. The findings include: 1. Observed around 8:30 a.m. July 17, 2018 a container of instant coffee stored in laboratory flame cabinet with chemicals considered to be hazardous materials. 2. An interview at approximately 11:30 a.m. July 17, 2018 with the laboratory manager and lead processor confirmed the laboratory director failed to ensure a procedure that prohibits anything other than chemicals and reagents be stored in the laboratory flame cabinet. ================================== D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: ================================== Based on lack of documented competency for 3 of 3 testing personnel performing KOH (potassium hydroxide testing), Wet Preps and Tzanck Smears and upon interview with the laboratory manager, determined the technical consultant failed to ensure documented annual competencies for 3 testing personnel since 2016. The findings include: 1. There were -- 2 of 3 -- no competencies documented for 3 of 3 testing personnel performing KOH, Wet Preps and Tzanck Smears since 2016. 2. An interview with the laboratory manager at approximately 11:30 a.m. July 17, 2018, confirmed the Technical Consultants failed to document annual competencies for 3 of 3 testing persons since 2016 performing KOH, Wet Preps and Tzanck Smears. ================================== -- 3 of 3 --