Ancillary Pathways, Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at ANCILLARY PATHWAYS, LLC on June 12, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited as follows: 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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document the acceptability of the negative control for Immunohistochemical (IHC) stains for three out of three patients with IHC stains in 2025. Findings included: 1-Review of the procedure manual signed by the Laboratory Director on 04/01/2026 in policy "QUALITY CONTROL & QUALITY MANAGEMENT", in section "SPECIAL STAINS & SLIDE STAINING QUALITY", stated "The pathologist assesses the staining quality of routine stains, and quality of immunohistochemical stains for intended reactivity. The quality control results are documented." 2-The laboratory performs only the microscopic examination of the slides. Three of five patient slides, and pathology reports had IHC stained slides. Review of three patient reports and slides, revealed the IHC stains listed per case: Patient#1 (P#1) reported by TP#2 on 09 /16/2025 listed the following IHC stains: Estrogen Receptor IHC stain (ER), Progesterone Receptor IHC stain (PR) , Human epidermal growth factor receptor 2- positive (HER2+), Nuclear Non-histone Protein IHC stain (KI-67). No reference to acceptability of positive and negative control. P#2 reported by TP#3 on 09/22/2025, listed following IHC stains: Glial fibrillary acidic protein (GFAP), KI-67, Protein 53 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 -- (P-53), ATRX, Antihuman isocitrate dehydrogenase 1 (IDH1). No reference to acceptability of positive and negative control. P#3 reported by TP#3 on 11/28/2025 listed the following IHC stains: GFAP, KI-67, ATRX, IDH-1. The IHC slides had positive control tissue. No reference to acceptability of positive and negative control. 3-Review of the Daily QC logs for 2025, for all four TP (TP#1, TP#2, TP3 an TP#4) revealed that every TP had a monthly log that listed acceptability of Hematoxylin & Eosin control, IHC, Special stains per day. This log failed to list cases reviewed per day, failed to list the IHC stains reviewed per day and the acceptability of positive and negative control for each stain reviewed. 4-During an interview on 07/16/2026 at 1:50 PM the Chief Executive Officer confirmed that the laboratory failed to have records of the acceptability of the positive and negative controls for the IHC listed in the cases reviewed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted from 08/21/2024 to 08/28/2024 found the ANCILLARY PATHWAYS, LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 staff interview, the laboratory failed to ensure that the patient report included the name and address of the laboratory that performed the Technical Component (TC) for 8 out of 8 reports reviewed (P#1, P#2, P#3, P#4, P#5, P#6, P#7 and P#8) in 2023-2024, and failed to identify the laboratory name and address of the laboratory that performed the Professional Component (PC) for 1 out of 8 reports reviewed for the period listed above. Findings Included: 1-Review of the 8 patient reports revealed the following: -Report for patients: P#1 (dated 12/22/2023, P#2 (dated 02/12/2024), P#3 (dated 02/19/2024, P#4 (dated 03/01/2024, P#5 (dated 03 /25/2024). P#6 (dated 03/27/2024, P#7 (dated 04/23/2024), P#8 (dated 05/15/2024) failed to include the name and address of the laboratory that performed the TC. - P#1 Report failed to include the name and address of the laboratory that performed the Professional Component (PC). During an interview on 08/21/2024 at 11:30 am, with Chief Executive Officer, she confirmed that the reports of reference failed to include 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 -- the name and address of the laboratory that performed the TC and failed to list the name and adress of the laboratory that performed PC for P#1. -- 2 of 2 --