Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Associates in Dermatology MDS PL on May 27, 2026 to June 5, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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 record review and interview, the laboratory failed to verify the accuracy of the H&E stain and IHC stains at least twice annually from 05/30/2024 to 05/27/2026. Findings Included: 1. Review of the test menu attached to the Clinical Laboratory Improvement Amendments application for certification (signed by the Laboratory Owner on 05/27/2026) revealed, the laboratory read out the following special stains: AFB (Acid Fast Bacilli, Mycobacterium stain), Gram Stain (Bacteria stain), Iron stain, and PAS (Periodic Acid Schiff, polysaccharides stain). The laboratory also reads the following IHC stains: BerEp4 (Epithelial Antigen IHC stain), CD3 (Cluster of Differentiation 3 T cell Lymphocytic IHC stain), CD10 (Cluster of Differentiation 10 dendritic cell IHC stain), CD20 (Cluster of Differentiation 20 B cell Lymphocytic IHC stain), CD31 (Cluster of Differentiation 31 endothelial cell IHC stain), CD34 (Cluster of Differentiation 34 progenitor cells IHC stain), CD45 (Cluster of Differentiation 45 leukocyte IHC stain), CD68 (Cluster of Differentiation 68 Monocytes and Tissue Macrophages IHC stain), CK7 (Cytokeratin 7 Protein IHC stain), CK20 (Cytokeratin 20 IHC stain), Desmin (Smooth Muscle Tumor IHC stain), HMB45 (Anti-Human Melanosome IHC stain), Ki-67 (Nuclear Non-histone Protein IHC stain), MART-1/Melan-A (Melanocytic Marker IHC stain), P63 (P63 gene IHC stain), Pan-Keratin (muscle creatine kinase antibody IHC stain), S100 (Neural Tissue 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 -- /Lesion and Melanoma IHC stain), and SOX-10 (Melanoma IHC stain). 2. Review of the QMP (Quality Management Plan) Review Log revealed, peer review was performed on 01/20/2025 and 01/08/2026. 3. On 06/03/2026 at 11:01 AM, the Lead Technician confirmed in an email that peer review was done on 01/20/2025 and 01/08 /2026. 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 patients' pathology final reports and interview, the laboratory failed to list the name (as it appears on the Clinical Laboratory Improvement Amendments Certificate), and address of the laboratory where the professional component was performed for three of three patients' reports reviewed, (#1, #2, #3). Findings Included: 1. Review of the pathology final reports revealed the name and address of the laboratory where the professional and the name of the laboratory where the technical component was performed was not listed on the reports. 2. On 06/05 /2026 at 9:36 AM, the Lead Technician stated the information was missing from the reports. -- 2 of 2 --