Mid Florida Dermatology Associates Pa

Summary Statement of Deficiencies D0000 A Recertification survey was conducted on November 15, 2022. Mid Florida Dermatology Associates PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document quality control information including the lot numbers, expiration dates, and open dates for all reagents used in their Sakura Tissue-Tek VIP 5 (Vacuum Infiltration Processor) and their Automated Leica Stainer, and the laboratory failed to have documentation of the preparation of the reagents used on the Sakura Tissue-Tek VIP 5 from 11/01/2020 to 11/18/2022. Findings: Review of the "Sakura VIP - 5 Processor #1 Maintenance" and the "Sakura VIP - 5 Processor #2 Maintenance" logs showed they did not list the lot numbers, expiration dates, and open dates of the reagents used on the processor. The Tissue Tek VIP used the following reagents: 10% Neutral Buffered Formalin, 70% Reagent Alcohol, 80% Reagent Alcohol, 95% Reagent Alcohol, 100% Reagent Alcohol, Xylene and Paraffin. The laboratory prepares the 70% Reagent Alcohol and 80% Reagent Alcohol. There was no log reflecting the preparation of the 70% Reagent Alcohol and 80% Reagent Alcohol solution used on the Tissue Tek VIP. Review of the "Automated Leica Stainer Maintenance" log showed the Hematoxylin stain and the Eosin Stain lot numbers and open dates were listed on the maintenance logs. The automated stainer log also showed that the Periodic Acid and Schiff's Reagent lot numbers and open dates were listed on 15 of 25 logs examined. The laboratory used the Automated Leica Stainer to stain tissue slide for the Hematoxylin 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 -- & Eosin stain (H&E) and Periodic Acid Schiff stain (PAS). The Automated Leica Stainer used the following reagents: Xylene, 100% Reagent Alcohol, 70% Reagent Alcohol, Hematoxylin Vintage stain, Define MX-aq, Blue Buffer 8, 95% Reagent Alcohol, Eosin-Y Vintage stain, Periodic Acid 5% Aqueous Solution, and Schiff's Reagent. Review of the laboratory's quality control records revealed there was no other reagent log. On 11/15/2022 at 1:30 PM, Testing Personnel C acknowledged not all the reagent lot numbers, expiration dates, and open dates were recorded and there was no log listing the lot numbers, expiration dates, and open dates of the reagents used to prepare the 70% and 80% Reagent Alcohol solutions. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain the documentation of the initial training and failed to perform a competency evaluation semiannually during the first year on 1 (C) of 2 (B-C) Testing Personnel who performed grossing (macroscopic physical examination/description) in the histopathology laboratory. Findings: Review of the histopathology laboratory's procedure "Competency Assessment" noted "After initial training and before working independently, a new employee's competency is assessed, and the assessment is documented on the training documentation." The procedure also noted "6 months after an employee has been deemed competent to work independently, competency is assessed, and the assessment is documented on competency assessment documentations." Review of the competency assessments for Testing Personnel C revealed the initial training competency assessment documentation was missing and the six-month competency assessment was performed on 11/30/2021. On 11/15/2022 at 12:55 PM, Testing Personnel B stated she was unable to locate the initial training competency assessment performed on Testing Personnel C and the six-month review was performed on 11/30/2021. On 11/15/2022 at 12:57 PM, Testing Personnel B stated Testing Personnel C started working in the laboratory on 11/02/2020. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 24, 2020. Mid Florida Dermatology Associates PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 record review and staff interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain, Special Stains, and Immunohistochemistry (IHC) stains at least twice in 2017. Findings: Review of the laboratory's records showed that there was only one "Peer Review Analysis Form" date 5/17/17, filled out on one patient for 2017. The laboratory uses peer review to evaluate the accuracy of the reading and interpretation of the H&E stain, special stains and IHC stains. The laboratory directory evaluates the following special stains: Alcain Blue (mucopolysaccharides and glycoproteins stain), Fontana Massom (melanin stain), Gram Stain (Bacteria stain), PAS (Periodic Acid Schiff, polysaccharides stain), and Perls Iron ( iron stain). The laboratory directory evaluates the following IHC stains: AE1/AE3 (Epithelial IHC stain), AFB (Acid Fast Bacilli IHC stain), Androgen Receptor IHC stain, BerEp4 (Epithelial Antigen IHC stain), CD1A (Cluster of Differentiation 1A gastrointestinal epithelium and cytoplasmic hepatocytes IHC stain), CD3 (Cluster of Differentiation 3 T cell Lymphocytic IHC stain), CD10 (Cluster of Differentiation 10 Cell Surface Enzyme IHC stain), CD20 (Cluster of Differentiation 20 B cell Lymphocytic IHC stain), CD30 (Cluster of Differentiation 30 Transmembrane Cytokine Receptor IHC stain), CD31 /PECAM1 (Cluster of Differentiation 31 also known as PECAM-1 platelet endothelial cell adhesion molecule-1 IHC stain), CD34 (Cluster of Differentiation 34 progenitor cells IHC stain), CD45 (Cluster of Differentiation 45 leukocyte IHC stain), CD117 (Cluster of Differentiation 117, stem cell IHC stain), CD123 (Cluster of Differentiation 123 hematopoietic progenitor cell IHC stain), CD163 (Cluster of Differentiation 163 monocyte and macrophage IHC stain) CK20 (Cytokeratin 20 IHC 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 -- stain), Chromogranin IHC stain, Congo Red (cutaneous amyloid IHC stain), Desmin (Smooth Muscle Tumor IHC stain), EMA (Epithelial Membrane Antigen IHC stain), Factor XIIIa (Factor XIIIa protein IHC stain), Fite (Microorganism IHC stain, HHV-8 (Herpes Virus Type 8 IHC Stain), HPV (Human Papillomavirus stain), HSV (Herpes Simplex Virus, Type I and II IHC stain), Melan-A (Melanocytic Marker IHC stain), MITF (Microphthalamia Transcription Factor IHC stain), MLH1 (MutL Homolog 1 Colorectal Cancer IHC stain), MSH2 (Melanocyte Stimulation Hormone 2 Tumor Suppressor Gene IHC stain), MSH6 (Melanocyte Stimulation Hormone 6 Colorectal Cancer and Endometrial Cancer IHC stain), NSE (Neuron Specific Enolase IHC Stain), PMS2 (Postmeiotic Segregation Increase 2 IHC stain), P63 (P63 gene IHC stain), S100 (Neural Tissue/Lesion and Melanoma IHC stain), SMA (Smooth Muscle Actin IHC stain), Spirochetes (Treponema Palladium IHC stain), Tryptase (Mast Cell IHC stain), and SOX-10 (Melanoma IHC stain). During an interview on 10/31/18 at 11 AM, the Laboratory Director acknowledged the peer review in 2017 was performed only once. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the open dates for some of the reagents used in their laboratory from 10/31/16 to 10/31/18. Findings: Record review of the laboratory's "Chemical Log" showed that the laboratory failed to record when the reagents were opened. Open dates for Xylene, 100%, 95% and 70% Alcohol, Bluing, Periodic Acid, Schiff Reagent, Formalin and Parapro SEM were not recorded. During an interview on 10/31/18 at 12:48 AM, Testing Personnel C acknowledged that the laboratory did not record open dates for reagents. -- 2 of 2 --