Advanced Dermatology Associates Ltd

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and interview with the histotechnician, the laboratory failed to monitor and document room temperature and humidity to ensure test system operating conditions were met for instrumentation used when histopathology examinations were performed for 22 of 22 months from 10/06 /2023 to the date of survey. Findings include: 1. On the day of survey, 08/19/2025 during the tour of the laboratory at 12:01 pm, the surveyor discovered the following instrumentation in use: - 2 of 2 Leica 2255 rotary microtomes - 1 of 1 Tissue Tek processor - 1 of 1 Ventana Benchmark Ultra autostainer - 1 of 1 Leica autostainer XL - 1 of 1 Leica CV 5000 cover slipper - 10 of 11 microscopes (s/n 6G0372, s/n 1D77229, s/n 4J04836, s/n 160142, s/n 704966, s/n 702930, s/n 704905, s/n 219364, s /n 86998, s/n 282498). 2. On the day of survey, 08/19/2025, the laboratory failed to provide acceptable criteria and documentation for monitoring room temperatures and humidity to ensure operating conditions were met for the above instrumentation used when histopathology slide examinations were performed for 22 of 22 months from 10 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 -- /06/2023 to 08/19/2025: 3. The laboratory performed 24,652 histopathology slide examinations in 2024 (CMS 116 estimated annual volume, dated 08/19/2025). 4. The histotechnician confirmed the findings above on 08/19/2025 at 12:08 pm. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Histotechnician, the laboratory failed to document a positive and negative control each day of patient testing for Potassium Hydroxide (KOH) and Scabies microscopic examinations performed for 22 of 22 months from 10/06/2023 to the day of survey. Findings include: 1. On the day of survey, 08/19/2025, the laboratory failed to provide documentation of the positive and negative control performed every day of patient testing for KOH and Scabies microscopic examinations performed from 10/06/2023 to 08/19/2025. 2. Review of the laboratory's KOH and Scabies testing procedures revealed the laboratory failed to include quality control instructions for each test. 3. The laboratory performed 922 KOH and 73 Scabies microscopic examinations from 05 /17/2023 to 04/10/2025. 4. The Histotechnician confirmed the above findings on 08/19 /2025 at 10:38 am. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's quality control (QC) staining records and interview with the histotechnician, the laboratory failed to check for negative staining reactivity each time of use for immunohistochemical (IHC) stains used for microscopic histopathology slide examinations performed for 22 of 22 months from 10 /06/2023 to the day of the survey. Findings Include: 1. On the day of the survey, 08/19 /2025 at 10:33 am, review of the laboratory's Daily Stain QC records revealed the laboratory failed to document negative and positive staining reactivity each time of use for IHC stains used for microscopic histopathology slide examinations performed from 10/06/2023 to 08/19/2025. 2. The laboratory performed 5177 histopathology examinations using IHC stains from 10/06/2023 to 08/19/2025. 3. The histotechnician confirmed the findings above on 08/19/2025 at 12:08 pm. B. Based on review of laboratory policy, quality control (QC) staining records and interview with the histotechnician, the laboratory failed to establish and document the laboratory's criteria for intended reactivity to ensure acceptable staining characteristics of special stains used for microscopic histopathology examinations performed for 22 of 22 months from 10/06/2023 to the day of the survey. Findings include: 1. The laboratory's "Policy for Evidence of Daily Review of the Technical Quality of Histological Preparations by Pathologist" states, "The pathologist will initial a quality -- 2 of 3 -- control log for routine Hematoxylin/Eosin (H&E), Special and Immunohistochemical (IHC) stains. If a stain or stains are not acceptable the pathologist will call the derm lab and initiate

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 review of the competency assessment policy, lack of documentation and interview with the testing personnel (TP) #22 and #24, the laboratory failed to follow their competency policy to assess the competency of 3 of 5 technical consultant (TC) from 10/18/2021 to the date of the survey. Findings include: 1. The laboratory competency assessment policy states, "Staff who hold CLIA supervisor positions: (general supervisor, technical consultant, technical supervisor, or clinical consultant), will be assessed annually for their supervisory competency in addition to laboratory". 2. On the day of survey, 10/06/2023 at 11:20 am, the laboratory could not provide the following personnel competency assessment records from 10/18/2021 to the date of the survey: - 3 of 5 TC 3. TP #22 and TP #24 confirmed the findings above on 10/06 /2023 around 1:20 pm. * This is a repeat deficiency. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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. 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 -- This STANDARD is not met as evidenced by: Based on review of the personnel competency assessment records and interview with the testing personnel (TP) #22 and #24, the technical supervisor (laboratory director) failed to evaluate the competency of 4 of 26 testing personnel who performed the Mohs testing from 10/18/2021 to the date of the survey. Findings include: 1. On the day of survey, 10/06/2023 at 11:09 am, the laboratory could not provide competency assessment documentation for 4 of 26 TP who performed Mohs testing from 10/18 /2021 to 10/06/2023. 3. TP #22 and TP #24 confirmed the findings above on 10/06 /2023 around 1:20 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 competency assessment policy, lack of documentation and interview with testing personnel (TP) #21 and #22, the laboratory failed to follow their competency policy to assess the competency of 03 of 04 technical supervisors in 2019 and 2020. Findings include: 1. The laboratory competency assessment policy states, "Staff who hold CLIA supervisor positions: (general supervisor, technical consultant, technical supervisor, or clinical consultant), will be assessed annually for their supervisory competency in addition to laboratory". 2. On the day of survey, 10/18 /2021, the laboratory could not provide the following personnel competency assessment records for 2019 and 2020: - 03 of 04 TS. 3. TP #21, TP #22 and the laboratory director confirmed the findings above on 10/18/2021 around 2:30 pm. B. Based on review of the competency assessment policy and interview with testing personnel (TP) #21 and #22, the laboratory failed to have a complete competency assessment policy that states to evaluate each testing personnel for each test performed in 2019 and 2020. Findings include: 1. On the day of survey, 10/18/2021, the laboratory could not provide a competency assessment policy that states to assess each TP for each microscopic examination analyzed (potassium hydroxide, scabies and tzanck) in 2019 and 2020. 2. The laboratory could not provide individual competency assessment documentation for each microscopic examination performed by TP in 2019 and 2020. 3. TP #21, TP #22 and the laboratory director confirmed the findings above on 10/18/2021 around 2:30 pm. 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 -- D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competency assessment records, peer review records and interview with TP #21 and TP #22, the technical consultant failed to assess the competency of all TP through internal blind testing samples or peer review in 2020. Findings Include: 1. The peer review for scabies, potassium hydroxide (KOH) and tzancks policy states, "peer review should be done once every 6 months for KOH and scabies slides per provider". 2. On the day of survey, 10/18 /2021, a review of TP competency assessment records and peer review records revealed, all testing personnel were not assessed through internal blind testing samples or peer review for KOH and scabies microscopic examinations in 2020. 3. TP #21, TP# 22 and the laboratory director confirmed the finding above on 10/18/2021 around 2:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of laboratory instrument maintenance records, review of the Cleaning, Maintenance and Service of Histology Equipment Policy and interview with the Testing Personnel (TP) #17 and #18, the laboratory failed to follow and document the maintenance of the Leica CV 3000 Coverslipper in 2018 (6 of 12 months). Findings include: 1. On the day of survey, 02/12/2019, review of maintenance records revealed the laboratory failed to document the daily, weekly, and monthly maintenance of the Leica CV 3000 Coverslipper in Februarys, March, June, October, November and December (6 of 12 months) in 2018. 2. In 2018, 39563 histology slides were prepared. 3. TP #17 and 18 confirmed the findings above on 02 /12/2019 around 11:30 am. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. 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 -- This STANDARD is not met as evidenced by: Based on review of personnel competency assessment procedure, personnel competency assessment records and interview with the Testing Personnel (TP) #17 and #18, the laboratory Director failed to ensure that policies and procedures were established for monitoring individuals performing delegated regulatory responsibilities for 9 of 10 personnel supervising Mohs, KOH and Scabies testing in 2017 to the date of survey. Findings Include: 1. On the date of survey, 02/12/2019, the lab was unable to provide a complete competency assessment policy that covered monitoring individuals performing delegated regulatory responsibilities for supervising the Mohs, KOH and Scabies testing. a. TP #2 to #9 (8 of 9) are listed on the CMS 209 Form as Clinical Consultants. b. TP #6 and #8 (2 of 2) are listed on the CMS 209 Form as Technical Consultants. c. TP #2 and #3 (2 of 3) are listed on the CMS 209 Form as Technical Supervisors and General Supervisors. \ 2. From 07/11 /2017 to 12/31/2017 - 20,12 Mohs, KOH, and Scabies patient tests were performed. 3. From 01/01/2018 to 12/31/2018 - 40,075 Mohs, KOH, and Scabies patient tests were performed. 4. From 01/01/2019 to 02/12/2019 - 463 Mohs, KOH, and Scabies patient tests were performed. 5. TP #17 and #18 confirmed the findings above on 02/12/2019 around 09:30 am **** KOH = Sodium Hydroxide D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 personnel competency assessment records and interview with the Testing Personnel (TP) #17 and #18, the Technical supervisor (laboratory Director) failed to evaluate the competency of 15 of 16 testing personnel who perform, Mohs, KOH, and Scabies testing from 2017 to the date of survey. Findings Include: 1. On the date of survey, 02/12/2019, review of TP annual competency assessments records revealed in 2017 and 2018, 15 of 16 TP (providers) who perform, Mohs, KOH, and Scabies testing were not assessed for competency. 2. From 07/11/2017 to 12/31/2017 - 20,12 Mohs, KOH, and Scabies patient tests were performed. 3. From 01/01/2018 to 12/31/2018 - 40,075 Mohs, KOH, and Scabies patient tests were performed. 4. From 01/01/2019 to 02/12/2019 - 463 Mohs, KOH, and Scabies patient tests were performed. 5. TP #17 and #18 confirmed the findings above on 02/12/2019 around 09: 15 am **** KOH = Sodium Hydroxide -- 2 of 2 --