Summary:
Summary Statement of Deficiencies 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 2023, 2024 and 2025 Technical Consultant (TC) competency records, absence of documentation, and interviews with the Laboratory Director (LD) and TC 03/20/25, the laboratory failed ensure TC competency was assessed and documented since 12/21/21, a period of approximately 51 months. Findings: Review of 2022, 2023, 2024 and 2025 TC competency records revealed the TC competency assessment was performed on 12/21/21, there was no documentation of an assessment in 2022, 2023, 2024 or 2025. During an interview at approximately 12:15 p.m., the TC confirmed there are no additional competency records available for review. During the exit interview at approximately 2:30 p.m., the LD stated he could not recall the last time the TC's competency was evaluated. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of 2023 American Proficiency Institute (API) proficiency testing (PT) records, absence of documentation and interview with TC 03/20/25, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- laboratory failed to review and verify the accuracy of "not graded" PT results. Findings: Review of 2023 API PT records revealed no documentation of a review to verify the accuracy of the following "not graded" PT results: 2023 Hematology /Coagulation - 1st event: Sample DXH-04 - Lymphocytes. 2023 Chemistry - Core - 2nd event: Samples CM-06 and CM-09 - Troponin. 2023 Hematology/Coagulation - 3rd event: Samples DXH-11 and DXH-14 - Lymphocytes. Interview with TC at approximately 11:10 a.m. confirmed the laboratory failed to review and verify the accuracy of the "not graded" PT results. They stated they were unaware they should be reviewed if they were not graded. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of operators manual for the DXH 520 hematology analyzer, review of 2023, 2024 and 2025 hematology maintenance logs, lack of documentation and interview with TC 03/20/25, the laboratory failed to perform yearly maintenance, "Lubricating Pistons", since time of last survey, 02/25/22, a period of approximately 25 months. Findings: Review of operators manual for the DXH 520 hematology analyzer revealed "Table 12.1 Matrix of Frequency for Cleaning Procedures". The table lists "Lubricating Pistons" and a frequency of "Yearly". Review of 2023, 2024 and 2025 hematology maintenance logs for the DXH 520 hematology analyzer revealed no documentation the yearly maintenance, "Lubricating Pistons", was performed since time of last survey, 02/25/22. Interview with TC at approximately 12: 00 p.m. confirmed the laboratory failed to perform the yearly maintenance as required in the operators manual. D5781