Dermatology Associates, Pc

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 documentation review and interview, the facility failed to perform twice annual verification on Mohs micrographic surgery (Mohs) testing for one (2024) of two years evaluated and two (Pt#1 and Pt#3) of seven patients reviewed. Findings include: 1. A review of the facility's proficiency testing for 2024 document titled, "Proficiency Comparison Studies", indicated one case was compared on 4/5/2024. 2. Review of patient records indicated the following patients had MOHS slides reviewed without proficiency testing twice annual verification being performed in 2024: Patient Date of Testing Pt#1 6/4/24 Pt#3 8/20/24 3. In an interview at 12:30 pm on 09/30 /2025, E1 (Office Manager) confirmed that one case study was performed for proficiency comparison studies in 2024. E2 also confirmed that the facility did not have a written policy for proficiency testing twice annual verification. 4. In an interview at 2:45 pm on 09/30/2025, E2 (Laboratory Director) confirmed that one case study was performed for proficiency comparison studies in 2024. E2 also confirmed that the facility did not have a written policy for proficiency testing twice annual verification, or a contract for comparison studies. 5. Annual test volume for Mohs is 150. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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, record reviews, and interview, the laboratory failed to monitor and document humidity for one of one cryostat (Leica CM1860 SN1520) for 11 of 11 months (January 2023 to November 2023) and seven (PT#1-PT#6, and PT8) of nine patients reviewed. Findings Included: 1. A tour of the MOHS Microscopic Surgery (MOHS) Laboratory on 11/28/2023 at 12:05 pm, revealed a cryostat used for MOHS testing, Leica CM1860 SN1520. 2. Review of the documents "Temperature Log" from January 2023 to November 2023 indicated there was no documentation for Humidity. 3. Review of the binder "CLIA regulations/manual", approved by Laboratory Director on 12/27/2017, revealed the procedure "Quality Control Policy and Documentation" required temperature checks and documentation, but did not require humidity check and documentation. 4. Review of the "Instruction Manual, Leica CM1850 V2.2 12 /2003" Section 3 page 12 "Technical data" requires that air humidity to be lower than 60 percent. 5. Review of patient's records revealed the following patient had MOHS testing performed when humidity was not monitored: a) PT#1 tested on 11 21/2023 for MOHS. b) PT#2 tested on 10/03/2023 for MOHS. c) PT#3 tested on 8/01/2023 for MOHS. d) PT #4 tested on 4/18/2023 for MOHS. e) PT#5 tested on 2/072023 for MOHS. f) PT#6 tested on 7/18/2023 for MOHS. g) PT#8 tested on 7/18/2023 for MOHS. 6. During interview on 11/28/2023 at 12:30 pm, Sp-3 (histology technician) 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 -- confirmed that humidity was not monitored or recorded. 7. Annual test volume for MOHS testing is 134. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to ensure four out of six tissue marking dyes (blue, green, red, and black) were not expired for MOHS Microscopic Surgery (MOHS) testing performed on seven (PT#1-PT#7) of seven patients reviewed. Findings included: 1.) During a MOHS laboratory tour on 1 /17/2023 at 11:10 am, four Tissue Marking Dyes (blue, green, red, and black) had expired in 2019. The dyes had the following expiration dates: blue- 09/2019, green- 05 /2019, black 08/2019, and red- 09/2019. 2.) Review of patient records revealed the following: a.) PT#1 was tested on 11/2/2021 for MOHS. b.) PT#2 was tested on 12/21 /2021 for MOHS. c.) PT#3 was tested on 4/19/2022 for MOHS. d.) PT#4 was tested on 5/17/2022 for MOHS. e.) PT#5 was tested on 1/10/2023 for MOHS f.) PT#6 was tested on 1/10/2023 for MOHS. g.) PT#7 was tested on 1/10/2023 for MOHS. 3.) During an interview on 1/17/2023 at 2:30 PM, SP-1 (Medical Assistant) and SP-2 (Office Manager) confirmed the blue, green, black and red tissue marking dyes had expired in 2019. 4.) The annual MOHS testing volume is 476. 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 D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director did not specify, in writing, the responsibilities and duties of 1 of 1 consultant, supervisor, and person engaged in the performance of preanalytic, analytic, postanalytic testing. Findings Include: 1. Review of personnel files indicated the Laboratory Director, who also serves as the Clinical Consultant, the Technical Supervisor, the General Supervisor and Testing Personnel failed to have a signed job description containing the duties and responsibilities for each of the above positions. 2. In interview on 9/2/18 at 12:30 p. m., the laboratory director confirmed there were no signed job descriptions for the above listed positions. 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 --