Jona K Gill, Md, Pc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on record review and interview with the Practice Manager (PM), the laboratory failed to ensure that 6 reagents used for histopathology tissue examination were not available for use beyond their expiration dates. Findings include: 1. On 10/29 /2025 at 9:45 am, the surveyor observed the following expired reagents: a. 1 of 2 bottles of Advantik Red Tissue Marking Dye with an expiration date of 6/30/2024. b. 1 of 2 bottles of Advantik Black Tissue Marking Dye with an expiration date of 6/30 /2024. c. 1 of 2 bottles of Advantik Green Tissue Marking Dye with an expiration date of 6/30/2024. d. 1 of 2 bottles of Advantik Yellow Tissue Marking Dye with an expiration date of 9/30/2024. e. 1 of 2 bottles of Advantik Blue Tissue Marking Dye with an expiration date of 7/31/2024. d. 1 of 5 bottles of Mercedes Scientific Eosin with an expiration date of 7/31/2025. 2. On 10/29/2025 at 9:50 am, an interview with the PM confirmed the reagents were expired. 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 D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Testing Personnel #3, the laboratory failed to follow specimen labeling policies and procedures for 1 (Patient "GE") of 1 patient tissue specimen observed. Findings include: 1. The surveyor observed testing personnel drop off a tissue specimen in a petri dish with a post-it note with "GE" set on top on 3/6/24 at 9:08 am. 2. A review of the laboratory's "Specimen Acceptance or Rejection" policy revealed a section stating, "When the specimen is received in the laboratory, it must be received accordingly: 1. It must be transported in a secondary container. 2. It must be labeled with the patient's name, date, specimen site, corresponding map with stage number." 3. An interview on 3/6/24 at 11:15 am with Testing Personnel #3 confirmed the laboratory had not followed it's specimen labeling policy. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #3, the laboratory failed to ensure histopathology procedures were approved, signed, and dated by the Laboratory Director for 1 (March 2023 to March 2024) of 1 year since the laboratory started testing. Findings include: 1. A review of the laboratory's procedure manual revealed a page titled "Policies and Procedures" stating, "The above policies and procedures have been reviewed and are effective as of open date. Updated as procedures change. Reviewed yearly." The section below this left a space for a signature with "Laboratory Director's Approval" and "Date" written underneath. No signature or date was present. 2. An interview on 3/6/24 at 9:40 am with Testing Personnel #3 confirmed the policies and procedures had not been approved by the Laboratory Director. -- 2 of 2 --