Aesthetic Dermatology Associates Pc

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 CLIA competency assessment record review and interview with the Registered Nurse (RN), the laboratory failed to perform the annual competency assessment of 1 of 3 Clinical Consultants (CC), 1 of 3 Technical Supervisor (TS), 1 of 3 General Supervisor (GS) and 1 of 9 Testing personnel (TP) for their supervisory and testing responsibilities for the histopathology section in 2021 and 2022. Findings Include: 1. On the day of the survey 08/02/2023 at 12:00 PM the laboratory could not provide 2021 and 2022 annual competency assessments for 1 of 3 CC (CMS-209). 2. The laboratory could not provide 2021 and 2022 annual competency assessments for 1 of 3 GS (CMS 209) for the histopathology slide review. 3. The laboratory could not provide 2021 and 2022 annual competency assessments for 1 of 3 TS (CMS 209, TP#7) for the histopathology slide review, parasitology, and mycology testing. 4. The laboratory could not provide 2021 and 2022 annual competency assessments for 1 of 9 TP (CMS 209) for the histopathology slide review. 5. The RN confirmed the above findings on 08/02/2023 around 01:30 PM. 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 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 -- performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, and an interview with Registered Nurse (RN), the laboratory failed to establish a maintenance protocol that ensures equipment performance for 1 of 1 thermometer used for Room Temperature (RT) and Humidity monitoring for the Histopathology testing from 7/27/2021 to the day of the survey. Findings include: 1. At the time of the survey, on 08/02/2023 at 12:30 PM, an observation of the laboratory revealed that the laboratory failed to document calibration activities for the following instruments. - Enviracaire Thermometer. 2. The laboratory failed to provide a calibration protocol for the accuracy of the thermometer listed above. 3. According to Laboratory's Room humidity policy and Room Temperature Policy for Mohs lab, the temperature should be between 60-73 degrees and the humidity should be 0-60% in the laboratory. 4. RN confirmed the findings above on 08/02/2023 at 01:30 PM. -- 2 of 2 --

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: A. Based on review of the laboratory's Competency Policy for MOHS Testing personnel and interview with Register Nurse (RN), the laboratory failed follow their policy to assess the competency of 1 of 2 laboratory personnel who performed the Clinical consultant (CC), Technical Supervisor (TS), and General Supervisor (GS) roles from 07/27/2019 to the date of survey. Findings include: 1. The laboratory's Competency Policy for MOHS Testing personnel states:"Staff who holds supervisor positions : (GS, TC, TS, or CC), will be assessed annually, for their supervisory competence in addition to laboratory testing competence." 2. On the day of survey, 07 /27/2021, the RN could not provide a competency assessment records for 1 of 2 personnel (CMS 209, listed as personnel #5) for their supervisory positions (CC, TS, GS, and CC) from 07/27/2019 to the date of survey. 3. The RN confirmed the finding above on 07/27/2021 around 09:29 a.m. B. Based on review of the laboratory's Competency Assessment procedure, annual competency records, and interview with Register Nurse (RN), the laboratory failed to establish a complete procedure that includes all six components required for competency assessment for 4 of 4 Testing Personnel (TP) who performed scabies examinations from 07/27/2019 to the date of survey. Findings Include: 1. On the day of survey, 07/27/2021, the RN could not provide a complete competency assessment policy to assess 4 of 4 TP who performed scabies examinations from 07/27/2019 to the date of survey. 2. The RN confirm the finding above 07/27/2021 at 09:44 a.m. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- 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 documentation and interview with the Register Nurse (RN), the laboratory failed to verify twice annually the accuracy of Potassium hydroxide (KOH) and scabies microscopic examination for 4 of 4 testing personnel (TP) who performed tests in 2020. Findings include: 1. On the day of survey, 07/27/2021, the laboratory could not provide documentation of verification of accuracy for KOH and Scabies microscopic examination for 4 of 4 TP who performed tests in 2020. 2. 9 KOH examinations were performed in 2020 3. 3 Scabies examinations were performed in 2020 3. The RN confirmed the findings above on 07/27/2021 at 10:08 a.m. -- 2 of 2 --

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 surveyor review of procedure manual and interview with the Registered Nurse (RN), the laboratory failed to establish and follow written procedures to assess 2 of 3 Mohs Testing Personnel (TP) competency which is required under subpart M in 2017 to the date of survey. Findings Include: 1. On the day of survey,02/26/2019, the laboratory could not produce a written procedure for the competency assessment for the Mohs TP. 2. The laboratory could not provide documentation of assessed competency for 2 of 3 TP (TP#4 and TP#6) from 2017 to 2018. 3. The RN confirmed the finding above on 02/26/2019 around 9:30 am. 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 review of laboratory records and interview with the Registered Nurse (RN), the laboratory failed to verify the accuracy of the microscopic examination for histopathology (Mohs macroscopic surgery) at least twice annually during 2018 as required for tests not included in subpart I. Finding Include: 1. On the day of survey, 02/26/2019, review of Mohs proficiency testing records revealed that in 2018 peer 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 -- review slides were pulled for review on 12/17/2018, peer review was not performed twice. 2. The RN confirmed the findings above on 02/26/2018 around 10:00 am. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of reagents and interview with the Registered Nurse (RN), the laboratory failed to label The Davidson Marking systems, Tissues marking dye Bottles (5 of 5) and The National Diagnostics Histo- Clear 1, Gallon Bottles (4 of 4) with expiration dates at the time of survey. Finding Include: 1. On the day of survey, the following reagents were observed with out expiration dates: a. The Davidson Marking systems, Marking dye Bottles: - 1 of 1 bottle of Blue Lot# 557-515160. - 1 of 1 bottle of Red Lot# 425-511201. - 1 of 1 bottle of Yellow Lot# 229-525290. - 1 of 1 bottle of Green Lot# 133-718220. - 1 of 1 bottle of Black Lot# 322-512240. b. The National Diagnostics Histo- Clear, Clearing Agent, 1 gallon Bottles: - 1 of 1 bottle, Lot# 04-18-24. - 3 of 3 bottles, Lot# 12-18-28. 2. The RN confirmed the findings above on 02/26/2019 around 11:15 am. D5781