Us Path Labs Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at US Path Labs LLC on May 5, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard level deficiencies cited are as follows: 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 observation, record review and interview, the laboratory failed to have a reagent log of the chemicals used in the Vacuum Infiltration Processor (VIP) and autostainer from 02/28/2024 to 05/05/2026. Findings Included: 1. Review of the US Path Labs Pegasus log revealed, the laboratory used the following reagents in their VIP: Formalin, Alcohol and Xylene. 2. Review of the Sakura Autostainer Quality Control (QC) log revealed, the laboratory used the following reagents in their H&E stain: Hematoxylin, Eosin, Alcohol, Xylene, and Acidic Alcohol. 3. Review of the laboratory's QC logs revealed, the laboratory did not have a log of the chemicals used in their VIP or autostainer. 4. During an interview on 05/05/2026 at 9:48 AM, the Vice President of Operations stated they did not have a log of the chemicals used. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of 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 -- all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel records, and interview, the Technical Supervisor (Laboratory Director) failed to document competency evaluations for seven (B - H) of eight Testing Personnel (A - H) in 2024, 2025, and 2026. Findings included: 1. Review of the personnel records for Testing Personnel B revealed there was no documentation of an initial competency in November 2024, and a sixth month competency evaluation in 2025. 2. Review of the personnel records for Testing Personnel C revealed the initial competency evaluation performed on 09/30/2025 and the sixth month competency evaluation performed on 04/02/2026 were not performed by the Technical Supervisor. 3. Review of the personnel records for Testing Personnel D revealed the initial competency evaluation performed on 10/31/2025 and the sixth month competency evaluation performed on 04/02/2026 were not performed by the Technical Supervisor. 4. Review of the personnel records for Testing Personnel E revealed the initial competency evaluation performed on 04/02/2026 was not performed by the Technical Supervisor. 5. Review of the personnel records for Testing Personnel F and G revealed the annual competency evaluations performed on 03/08/2026, 04/01/2025, and 4/02/2026 were not performed by the Technical Supervisor. 6. Review of the personnel records for Testing Personnel H revealed the initial competency evaluation performed on 10/08/2025 and the sixth month competency evaluation performed on 04/02/2026 were not performed by the Technical Supervisor. 7. During an interview on 05/05/2026 at 11:30 AM, the Vice President of Operations revealed there was no competency on the second Dermatopathologist (Testing Personnel B), and she reviewed and signed the competency evaluations for Testing Personnel C - H. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 01/07/2022 found that US PATH LABS LLC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory failed to document the lot numbers and expiration dates of the reagents used on the Tissue Tek VIP (Vacuum Infiltration Processor) and for the making of the 70 %, 80 % and 95 % alcohol solutions used on the Tissue Tek VIP from 01/07/2020 to 01/07/2022. Findings include: -Examination of the Tissue Tek VIP on 01/07/2022 at 11:30 AM, showed the Tissue Tek used the following reagents: Xylene, Alcohol 100 %, Alcohol 95 %, Alcohol 80 %, and Alcohol 70 %. -Review of the Tissue Tek Maintenance log, showed that the laboratory failed to record: a) Lot numbers and expiration dates for Xylene and Alcohol 100 %. b) Preparation and expiration date for the following solutions: 95 % alcohol, 80 % alcohol and 70 % alcohol and the lot number for the reagents used in the preparation. During an interview on 01/07/2022 at 01.00 PM, the laboratory manager confirmed that the laboratory failed to keep record of the lots used and failed to document the alcohol solutions preparation used on the Tissue Tek VIP. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES 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 -- CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) failed to do annual competency assessment for 1 out of 6 Testing Personnel (TP) in 2020 and 2021. Findings include: -Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 01/11/2022 revealed that: - LD was TS, GS and TP F. -The laboratory had 4 TP that were Grosser (TP B, TP C, TP D and TP E) and TP A was a Pathologist. -Personnel records review revealed that the TS failed to do annual competency for TP A for year 2020 and 2021. During an interview on 01 /07/2022 at 1:25 PM, with Laboratory Manager, she confirmed that the TS failed to do the annual competency assessment of reference. -- 2 of 2 --