Define Dermatolgoy, Pllc

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient Mohs maps and confirmed in interview, the laboratory failed to include the testing facility address on the patient Moh's maps for 10 of 10 patients in 2024 (random review December) and 12 of 12 patients in 2025 (random review September). Findings included: 1. A random review of patient Mohs maps from December 2024 and September 2025 revealed the following 22 patient Mohs maps which did not include the testing facility address: 12/5/2024 Patient Date of Birth: 09/10/1939, 08/21/1944, 05/18/1963, 01/11/1944, 10/12/1933, 03/11/1951, 08 /07/1951, 05/26/1940, 06/11/1957, 09/16/1934 09/03/2025 Patient Date of Birth: 06/17 /1949, 01/25/1952, 08/07/1949, 01/10/1939, 10/02/1940, 07/27/1957, 06/18/1954, 04 /28/1963, 02/22/1957, 07/06/1958, 01/15/1947, 08/04/1946 2. During an interview on 09/10/2025 at 2:08 p.m., the Mohs histotechnician, after a review of records, confirmed the laboratory failed to include the testing facility address on the patient Moh's maps. 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 D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, quality control (QC) logs, and confirmed in interview, the laboratory failed to define and document the intended reactivity for Hematoxylin and Eosin (H & E) staining to ensure predictable staining characteristics of quality control slides on each day of patient testing for eight of eight months reviewed in February 2024 (June 2023-January 2024). Findings Included: 1. Review of manufacturer's instructions, "MER 41311GL Mercedes Scientific Eosin Y Stain Solution Specifications" (Revised 2019) revealed the following: "Eosin Y is most commonly used cytoplasmic stain because of vivid pink color development." Review of manufacturer's instructions, "Mercedes Scientific Hematoxylin Stain Solution, Gill 3" (Revised 2019) revealed the following: "Hematoxylin Gill III used with Eosin Y Stain Solution produces the following results: Nuclei- Stained Blue Cytoplasm- Stained Pink." 2. Review of laboratory QC logs, "Quality control Analysis Log Sheet for Histopathology (Mohs Surgery)" from June 2023-January 2024, revealed the laboratory failed to define and document H & E intended reactivity to ensure predictable staining characteristics for eight of eight months reviewed. The 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 -- surveyor requested documentation of intended H & E staining reactivity, and none was provided. 3. During an interview on 02/27/2024 at 1:48 PM in the laboratory, the Laboratory Director confirmed the above findings. 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 CMS (Center for Medicare and Medicaid Services)- 209 form, surveyor observation, personnel records, patient annual volumes, and confirmed in interview, the Technical Supervisor failed to ensure training was performed in high complexity testing for one of one testing persons reviewed in 2024. Findings Included: 1. Review of CMS-209 form submitted at time of survey, revealed one of one testing persons (TP-1) performing high complexity histopathology testing. The date of hire for this facility was June 2023. 2. During a tour of the facility on 02/27/2024 at 1:03 PM, the surveyor observed TP-1 performing histopathology testing. 3. Review of personnel documentation from June 2023-January 2024, revealed no documented training for TP-1 in high complexity histopathology testing. The surveyor requested documentation of the above training, and none was provided. 4. Review of laboratory patient volumes, revealed the laboratory performed 967 histopathology tests from June 2023-January 2024. 5. During an interview on 02/27/2024 at 1:31 PM in the laboratory, the Laboratory Director confirmed the above findings. -- 2 of 2 --