Nosky Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Nosky PA on March 24, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, review of the Safety Data Sheets (SDS), and interview, the laboratory failed to ensure protection from chemical hazards used in their vacuum infiltration processor (VIP) and Hematoxylin and Eosin (H&E) stain from 03/11/2024 to 03/24/2026. Findings Included: 1. During tour of the laboratory on 03/24/2026 at 9: 30 AM, three containers used to store chemical waste were seen on the floor in a closet 2. Review of the procedure titled, Specimen Processing, signed and dated by the Laboratory Director on 01/05/2026 revealed the laboratory used the following reagents in their VIP processors: 10% Formalin, 70% Reagent Alcohol, 95% Reagent Alcohol, 100% Reagent Alcohol, and Xylene Substrate. 3. Review of the procedure titled, Routine Hematoxylin and Eosin, signed and dated by the Laboratory Director on 01/05/2026, revealed the laboratory used the following reagents for the H&E stain: Xylene Substrate, 100% Reagent Alcohol, 95% Reagent Alcohol, Hematoxylin, Acid Rinse, Bluing Reagent, Eosin, and Xylene. 4. Review of the Safety Data Sheets for the Stat Lab Eosin with Pheloxine B noted, "Keep in fireproof place." 5. Review of the SDS for the Mercedes Scientific 100% Reagent Alcohol, Mercedes Scientific 95% Reagent Alcohol, Mercedes Scientific 80% Reagent Alcohol, Mercedes Scientific 70% Reagent Alcohol, and Mercedes Scientific Xylene Substitute noted, "Store locked up." 6. Review of the SDS for the Mercedes Scientific 100% Reagent Alcohol, 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 -- Mercedes Scientific 95% Reagent Alcohol, Mercedes Scientific 80% Reagent Alcohol, and Mercedes Scientific 70% Reagent Alcohol noted "Store in an approved Flammable Liquids storage area." 7. During an interview on 03/24/2026 at 9:48 AM, the General Supervisor acknowledged the chemical waste was stored on the floor of the closet. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document maintenance and function checks for the Miles Scientific Tissue Tek Vacuum Infiltration Processor (VIP) used for large runs from 05/09/2024 to 03/24/2026, and failed to document maintenance and function checks for the Thermo Scientific Autostainer 360 used for Immunohistochemical (IHC) staining from January 2025 to 03/24/2026. Findings included: During tour of the laboratory on 03/24/2024 at 9:40 AM, two tissue tech VIP processors and two autostainers used for IHC stains were observed. Review of the AP Laboratory Equipment Maintenance Log noted the log did not indicate which VIP processor the maintenance was for. Review of the Immunohistochemical Staining Quality Control log revealed the log did not indicate which autostainer the maintenance was for. During an interview on 03/24/2026 at 11:05 AM, the General Supervisor stated he was recording the maintenance for both of the two VIPs together and both of the autostainers together. During an interview on 03/24/2026 at 12:30 PM, the General Supervisor explained they started using the second VIP for large runs on 05/09/2024. During an interview on 03/24/2026 at 1:34 PM, the General Supervisor indicated they started using the second autostainer for large runs in January 2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Recertification survey was conducted on March 11, 2024. Nosky PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 review of peer review records and 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 in 2022. Findings: The laboratory used peer review (proficiency) to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain, Special Stains, and Immunohistochemistry (IHC) stains. Review of the laboratory's policy titled "Proficiency Program" noted that "Random cases are sent out for a blind review twice annually to assess the performance of the pathologist (at least 20 cases) per year." The Laboratory Directory evaluates the following special stains: AFB (Acid Fast Bacilli, Mycobacterium stain), Collodial Fe (iron stain), Fite ((Acid Fast Bacilli, Mycobacterium leprae stain), Giemsa (histological stain), Gram Stain (Bacteria stain), PAS (Periodic Acid Schiff, polysaccharides stain), and VVG (Verhoeff-Van Gieson, elastic fibers stain). The Laboratory Directory evaluates the following IHC stains: BerEp4 (Epithelial Antigen IHC stain), Chromogranin (Neuroendocrine cell IHC Marker), CD1A (Cluster of Differentiation 1A gastrointestinal epithelium and cytoplasmic hepatocytes IHC stain), CD3 (Cluster of Differentiation 3 T cell Lymphocytic IHC stain), CD4 (Cluster of Differentiation 4 T cell Lymphocytic IHC stain), CD5 (Cluster of Differentiation 5 T cell Lymphocytic IHC stain), CD7 (Cluster of Differentiation 7 T cell Lymphocytic IHC stain), CD8 (Cluster of Differentiation 8 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 -- 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 (Cluster of Differentiation 31 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), CEA (Carcinoembryonic Antigen IHC stain), CD68 (Cluster of Differentiation 68 transmembrane glycoprotein), CK7 (Cytokeratin 7 Protein IHC stain), CK20 (Cytokeratin 20 IHC stain), D-240 (Podoplanin, lymphatic endothelial IHC stain), EMA (Epithelial Membrane Antigen IHC stain), Factor XIIIa (Factor XIIIa protein IHC stain), Fite (Microorganism IHC stain), HMB-45 (Melanoma-associated marker IHC stain), KI-67 (Cell proliferation marker IHC stain), Melan-A/MART-1(Melanocytic Marker IHC stain), MITF (Microphthalamia Transcription Factor IHC stain), Pank-AE1/3 (Epithelial IHC stain), pHH3 (Phosphohistone H3 Protein IHC stain), PRAME (Melanoma IHC stain), S100 (Neural Tissue/Lesion and Melanoma IHC stain), SOX-10 (Melanoma IHC stain), and Synapto (Neuroendocrine IHC stain). Review of the peer review records revealed the peer review was done once in 2022 on 09/09/2022. On 03/11/2024 at 3: 45 PM, Testing Personnel A acknowledged the peer review was done only once in 2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 19, 2019. Nosky PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 in 2018 using a blind peer review. Findings: Review of the laboratory's policy titled "Proficiency Program" noted that "slides sent out for a second opinion will be used to assess then performance of the pathologist. The laboratory's form titled "Anatomic Pathology Consultation / Peer Review" listed slides sent out for second opinions. The laboratory used the consults 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: AFB (Acid Fast Bacilli, Mycobacterium stain), Alcain Blue (mucopolysaccharides and glycoproteins stain), Collodial Fe (iron stain), Fite ((Acid Fast Bacilli, Mycobacterium leprae stain), Giemsa (histological stain), Gram Stain (Bacteria stain), PAS (Periodic Acid Schiff, polysaccharides stain), and VVG (Verhoeff-Van Gieson, elastic fibers stain). The laboratory directory evaluates the following IHC stains: AE1/AE3 (Epithelial IHC stain), BerEp4 (Epithelial Antigen IHC stain), Chromogranin (Neuroendocrine cell IHC Marker), CD1A (Cluster of Differentiation 1A gastrointestinal epithelium and cytoplasmic hepatocytes IHC stain), CD3 (Cluster of Differentiation 3 T cell Lymphocytic IHC stain), CD4 (Cluster of Differentiation 4 T cell Lymphocytic IHC stain), CD5 (Cluster of Differentiation 5 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 -- T cell Lymphocytic IHC stain), CD7 (Cluster of Differentiation 7 T cell Lymphocytic IHC stain), CD8 (Cluster of Differentiation 8 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 (Cluster of Differentiation 31 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), CD68 (Cluster of Differentiation 68 transmembrane glycoprotein), CK7 (Cytokeratin 7 Protein IHC stain), CK20 (Cytokeratin 20 IHC stain), D-240 (Podoplanin, lymphatic endothelial IHC stain), EMA (Epithelial Membrane Antigen IHC stain), Factor XIIIa (Factor XIIIa protein IHC stain), Fite (Microorganism IHC stain), HMB-45 (Melanoma-associated marker IHC stain), KI- 67 (Cell proliferation marker IHC stain), Melan-A/MART-1(Melanocytic Marker IHC stain), MITF (Microphthalamia Transcription Factor IHC stain), pHH3 (Phosphohistone H3 Protein IHC stain), S100 (Neural Tissue/Lesion and Melanoma IHC stain), SOX-10 (Melanoma IHC stain), and Synapto (Neuroendocrine IHC stain). During an interview on 9/19/19 at 1244 PM, the Testing Personnel B acknowledged that the slides and diagnosis on patients were sent out when a second opinion was requested. Testing Personnel B also acknowledged that the use of the consult slides for the peer review wasn't a blind peer review and that the "Anatomic Pathology Consultation / Peer Review" didn't provide a space to indicate if the two doctors agreed on the diagnosis. D5805 TEST REPORT CFR(s): 493.1291(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 record review and interview, the laboratory's patient final report failed to list the correct address of the laboratory where the histopathology testing was performed for 4 out of 4 patient final reports examined, (#1, #2 #3 and #4). Findings: Review of the "Surgical Pathology Report" for patient #1, #2, #3 and #4 showed that the laboratory's address was incorrect. During an interview on 9/19/19 at 1:34 PM, the Testing Personnel B acknowledged that the surgical report did not have the correct address. -- 2 of 2 --