Accordia Healthcare, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on June 3, 2021. Condition and Standard level Citations were found. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the daily Quality Control (QC) for the Horiba Hematology Analyzer, (Horiba), the laboratory failed to verify the QC performed in January 2021 thru April 2021, met the acceptable guidelines before patient sample results were released. The laboratory released 78 patient results, when the QC was out of range on 17 days from January 2021 thru April 2021. Reference :D6020, D6024 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the Quality Control (QC), for the Horiba Hematology Analyzer (Horiba), the Laboratory Director (LD) failed to ensure the quality control program is established and maintained to assure the quality of laboratory services being provided. Findings: 1. Review of the QC documents for the Horiba, for the month of January showed that the QC was out of range for the analyte White Blood Cell (WBC) for the High, Normal and Low for the following days, and patient results were reported out: 1-9-2021 the High and Normal levels for WBC were out of range, 5 patients had WBCs reported 1-10-2021 the High and Normal levels for WBC were out of range, 6 patients had WBCs reported 1-14-2021 the High and Normal levels for WBC were both out of range, 5 patients had WBCs reported 1-22-2021 the High, and Low levels for WBC were out of range, 4 patients had WBCs reported 1-24-2021 the High, Normal and Low levels for WBC were out of range, 4 patients had WBCs reported 2-01-2021 the High, and Normal levels for Red Blood Cell (RBC) QC were out of range, 8 patients had RBC's reported 2-02-2021 the High and Low levels for RBC were out of range, 4 patients had RBC's reported 2-03-2021 the High and Normal levels for RBC were out of range, 2 patients had RBC's reported 3-09-2021 the High and Normal levels for WBC were out of range, 3 patients had WBCs reported 3-13-2021 the High and Normal levels for WBC were out of range, 2 patients had WBCs reported 3-17-2021 the High and Normal levels for WBC were out of range, 5 patients had WBCs reported 3-21-2021 the High and Normal levels for WBC were out of range, 1 patient had WBCs reported 3-23-2021 the High and Normal levels for WBC were out of range, 4 patients had WBCs reported 3-24-2021 the High and Normal levels for WBC were out of range, 2 patients had WBCs reported 3-25- 2021 the High and Normal levels for WBC were out of range, 6 patients had WBCs reported 3-31-2021 the High and Normal levels for RBC were out of range, 11 patients had RBCs reported 4-5-2021 the High and Normal levels for WBC were out of range, 6 patients had WBCs reported. 2. Review of the QC for the Horiba, for the months of January thru April 2021 confirmed the analyte WBC was out of range for the following consecutive days for each month as follows: January 2021 - The WBC was out of range for 23 consecutive days, with no

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 23, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the Horiba 60, Hematology Analyzer Quality Control (QC) documents and staff interfiew the laboratory was releasing Hematology patient results even when the QC was not within acceptable range. Findings: 1. Review of the QC documents for the Horiba 60 hematology analyzer showed that from October 11, 2017 to October 18, 2017, the QC was not acceptable on two out of the three controls. There were 28 Hematology patient samples tested and reported during the aforementioned dates that the control results were not within an acceptale range. For dates December 20, 21, 22, 2017, it appeared the dates were deleated from the monthly QC reports but individual instrument printouts were located and the QC results were not acceptable. There were 17 Hematology patient samples tested and reported during the dates. 2. Interview with staff #7 (CMS form 209) on January 23, 2019 at approximately 3pm in the staff breakroom, confirmed that patients samples were being tested when the QC was not acceptable in October, and December 2017. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(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 -- The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the Horiba 60 Hematology Analyzer Quality Control (QC) documents, the Laboratory Director (LD) failed to assure the quality of laboratory services provided and to identify failures in quality as they occur. Findings: 1. Based on review of the Horiba 60 Hematology QC documents, the laboratory failed to assure the quality of the hematology results before allowing patients to be reported. From October 11 thru the 18, 2017, and December 20, 21 and 22, 2017 the Hematology QC was not within an acceptable range, and patient sample were ran and resulted. 2. Interview with staff #7 (CMS 209 form) on January 23, 2019 at approximately 3:30 pm in the staff breakroom, confirmed that the LD failed to assure the quality of laboratory services for the QC, from October 11 thru the 18, and December 20 thru the 22, 2017. -- 2 of 2 --