Treasure Coast Pathology Lab Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Treasure Coast Pathology Lab LLC on June 17, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 interview, observation, review of quality control (QC) logs, reagent safety data sheets and equipment manuals, the laboratory failed to ensure protection from chemical hazards from 02/01/2023 to 06/17/2025. Findings: 1. Tour of the laboratory on 06/17/2025 at 1:15 PM, revealed there were two fume hoods, a Labconco Fume Absorbers Model 115V 3955200 Organic 30 inch and a Labconco Fume Absorbers Model 115 V 3955201 Formaldehyde 30 inch. The following reagents were used under the organic fume hood: Xylene, Hematoxylin, Eosin Y Solution, Vintage Bluing, A 100% Reagent Alcohol, and 95% Reagent Alcohol. The 10% Neutral Buffered Formalin was used under the Formaldehyde fume hood. 2. Review of the Fume Hood QC Logs: (#1 - Organic Filter / #2 - Formaldehyde Filter) showed the filters for the organic hood wee replaced on 02/12/2024 and 3/12/2025, and the filters for the formaldehyde hood were replaced on 02/09/2023, 02/12/2024 and 3/12/2025. 3. Review of equipment manuals for the hoods provided instructions on how to calculate the carbon filters' life to determine how often the filters should be changed. 4. Review of the Safety Data Sheets showed the 10% Neutral Buffered Formalin and Xylene are GHS (Globally Harmonized System) Carcinogenicity classification Category 2 . According to Occupational Safety and Health Administration (OSHA) 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 -- Hazardous Communication Standard 29 CFR 1910.1200 a GHS Carcinogenicity Category 2 is a substance that is suspected of causing cancer in humans. 5. Review of the Safety Data Sheets showed High Def and Hematoxylin may cause respiratory irritations. 6. During an interview on 06/07/2025 at 3:30 PM, Testing Personnel A stated they changed the filters once a year and she had never calculated the filter life. 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 review of quality control documents and interview, the laboratory failed to document the daily maintenance of the Hematoxylin and Eosin (H&E) stain from 03 /12/2024 to 06/17/2025. Findings: Review of the the Daily Maintenance Chart for H&E Staining showed there was no documentation from 03/12/2024 to 03/31/2024, 04 /12/2024 to 04/30/2024, and 06/01/2024 to 06/17/2025. During an interview on 06/17 /2025 at 3:50 PM, Testing Personnel A said she stained slides every day and had not kept up with the recording of the maintenance of the H&E stain. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 19, 2023. Treasure Coast Pathology Lab LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency records and procedure manual, and interview, the laboratory failed to document the competency assessment for one of one testing personnel who is also the general supervisor for 2021 and 2022. Findings: Review of the Laboratory Personnel Report signed and dated on 04/19/2023 by the Laboratory Director showed there were only two people listed on the report. The same person was the laboratory director, clinical consultant, and technical supervisor, and another person was the general supervisor and testing personnel. Review of competency evaluations for 2021 and 2022 showed the evaluations on the Testing Personnel was not signed by the Laboratory Director. Review of competency evaluations for 2021 and 2022 also showed the evaluations did not include all the job duties performed by the testing personnel and general supervisor. Review of the procedure manual revealed a form titled "Competency Evaluation of Technical Staff." The competency evaluation for the technical staff was not filled out on the testing personnel. On 04/19 /2023 at 12:52 PM, General Supervisor stated that the competency evaluations were not signed by the Laboratory Director and that she did not know whose signature was on them. On 04/19/2023 at 1:00 PM, General Supervisor agreed the competency evaluations filled out did not apply to her job duties. 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 -- 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 D0000 A Recertification survey was conducted on March 30, 2021. Treasure Coast Pathology Lab, LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5785

Summary Statement of Deficiencies 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)