Dmg Dermatology Institute

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 review of the laboratory's policies and procedures, cryostat maintenance records, and interview with the testing personnel (TP) #9; the laboratory failed to record cryostat temperatures for six of six days of patient testing reviewed for Mohs micrographic surgery. Findings include: 1. Review of the laboratory's policy and procedure manual revealed the procedure titled "Mohs tissue processing and mapping protocol" which stated " 6. Ensure the cryostat temperature is set at the optimum cutting temperature, between -18 and -35 degrees (C). 7. Update logs for temperature." 2. Review of "Cryostat maintenance record" documents revealed the laboratory failed to document cryostat temperatures for six of six patient testing days reviewed for Mohs micrographic surgery testing. Mohs Case #: Date of testing: SM24- 346 04/19/2024 SM24-656 07/11/2024 SM25-01 01/09/2025 SM25-533 05/05/2025 SM25-1602 12/18/2025 SM26-96 01/22/2026 3. Interview with TP #9 on 04/09/2026 at 11:36 am confirmed the laboratory failed to record cryostat temperature prior to use for six of six patient testing days. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) 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 -- (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Review of the laboratory's policies and procedures, personnel records, lack of documentation, and interview with the laboratory representative; the technical supervisor (TS) failed to ensure competency evaluations were completed for three of eight testing personnel (TP) that performed potassium hydroxide (KOH) preparations. Findings Include: 1. Review of the laboratory's policy and procedure manual revealed the policy titled "Derm Lab Competency Assessment Policy" which stated: "Policy Competency of personnel is assessed on an on-going basis with appropriate intervention when necessary. Assess and document the performance of individuals responsible for testing semiannually during the first year and annually thereafter." 2. Review of laboratory personnel records revealed no competency assessments for three of eight TP listed on the CMS-209 as TP #4, #5 and #6 for KOH preparations in 2025. 3. On survey date 04-09-26, at 10:30 am, the laboratory representative confirmed that the laboratory failed to perform competency assessments for three of eight TP that perform KOH preparations. -- 2 of 2 --

Summary Statement of Deficiencies 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. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with laboratory director (LD); the laboratory failed to document pathology immunohistochemical (IHC) staining positive and negative reactivity / quality control (QC) as required by 493.1256 for three of three patient IHC testing dates reviewed. Findings Include: 1. The laboratory's "City Gate MOHS Immunohistochemistry (MART-1)" procedure was reviewed and stated the following regarding IHC staining: "MART-1 positive control is cut and run prior to running patient tissue. Controls are collected and approved by Dr. Mehta. (and stored in freezer for future use)" 2. Review of patient testing results for three of three IHC stain testing dates found that no IHC staining positive and negative reactivity / QC was documented for these days of IHC stain testing. Report Date: Patient ID: Types of IHC Stain: 10/19/2022 SM22-1125 Mart 1 01/04/2023 SM23-11 Mart 1 07/11/2023 SM23-620 Mart 1 3. On 02/27/2024, at 02:40 pm, the LD confirmed the above findings. 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 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 -- test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of laboratory records, CMS-209 (Laboratory Personnel Report), lack of documentation, and interview with a laboratory representative; the technical consultant failed to ensure competency evaluations for one of five testing personnel (TP) performing Provider-Performed Microscopy (PPM) at the laboratory testing facility in the years of 2022 and 2023. Findings include: 1. Review of the CMS-209 revealed five TP performing PPM testing of Potassium Hydroxide (KOH) and scabies. 2. Review of laboratory competency evaluation records revealed that one of five TP performing PPM testing lacked documentation of competency performed at the testing laboratory. 3. An interview with a laboratory representative on 02/27/2024, at 12:36 pm, confirmed the above findings. -- 2 of 2 --