Schweiger Dermatology Group

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 lack of documentation and interview with the General Manager (GM), the laboratory failed to monitor and document room humidity to ensure operating conditions were met for 1 of 1 Leica DM1000 microscope and 1 of 1 Avantik cryostat (QS12) for histopathology (Mohs) microscopic slides from 11/01/2023 to 04/30/2025. Findings include: 1. The manufacturers operating environment specifications stated the following: -Leica DM 1000 microscope: 5-35 degrees Celsius (ambient temperature); maximum 80 % relative humidity - Advantik Cryostat: 5-35 degrees Celsius (ambient temperature); maximum 60% relative humidity. 2. On the day of the survey, 10/14/2025, the laboratory failed to provide documentation for the monitoring of room humidity to ensure operating conditions were met for the following instruments used to perform histopathology (Mohs) microscopic examinations from 11 /01/2023 to 04/30/2025: - 1 of 1 Lecia DM1000 microscope - 1 of 1 Avantik cryostat (QS12) 3. The laboratory performed 2991 histopathology slide examinations in 2024 (CMS 116, estimated annual volume, dated 09/24/2025). 4. The GM confirmed the above findings on 10/14/2025 at 09:30am. 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 documentation and interview with the General Manager (GM) , the laboratory failed to verify twice annually the accuracy of Potassium Hydroxide (KOH) and Scabies microscopic examinations from 02/02/2022 through the date of the survey. Findings include: 1. On the day of survey, 10/10/2023 at 10:58 am, the laboratory could not provide documentation of verification of accuracy for KOH and Scabies microscopic examinations performed from 02/02/2022 through the date of the survey. 2. The laboratory could not provide a procedure for the verification of accuracy for KOH and Scabies upon request by the surveyor. 3. The laboratory reported a total of 17 tests were performed annually (CMS116). 4. The GM confirmed the findings above on 10/10/2023 at 11:35 a.m. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with the General 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 -- Manager (GM), the laboratory failed to document a positive and negative control each day of patient testing for Potassium Hydroxide (KOH) and Scabies microscopic examinations from 02/10/2022 to 06/21/2023. Findings include: 1. On the day of survey 10/10/2023 at 10:39 am, review of KOH and Scabies QC records revealed the laboratory did not document the positive and negative visual control every day of patient testing . 2. The KOH and scabies examination procedure did not include a step to check visual quality control. 3. The laboratory reported a total volume of 17 tests were performed annually (CMS116). 4. The GM confirmed the above findings on 10 /10/2023 at 11:35AM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with General Manager (GM), the Technical Consultant (TC) failed to evaluate and document the annual competency for 2 of 4 Testing Personnel (TP) who performed Potassium Hydroxide (KOH) and Scabies microscopic examinations from 02/02/2022 to date of survey. Findings include: 1. On the day of survey 10/10/2023 at 10:12 am, the laboratory could not provide documentation of the annual competency assessment for KOH and scabies for TP #3 and TP #4 (CMS209 personnel number 3 and 4). 2. GM confirmed the finding above on 10/10/2023 at 11:35am. -- 2 of 2 --