Summary:
Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) (a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on procedure manual and quality assurance (QA) record review, and interview with the laboratory manager (LM), the laboratory failed to retain all hematology quality system assessment records for at least two years. Findings: 1. The laboratory manages and evaluates their hematology quality control (QC) by using the manufacturer's "Insight Quality Assurance Program (QAP)" which compares their QC results to a peer group for each lot number (#) of QC. 2. The procedure, "Sysmex XN- 1000 and XN-2000 Procedure" states that the laboratory should print and save QC data to "removable media" and that the "CV [Coefficient of Variation] must be reviewed and any changes in CV must be documented with investigation if needed." 3. Record review showed that the laboratory printed "Sysmex Insight" "XN Check" "Lot-to-Date" reports for the different lot # of hematology QC run on the Sysmex hematology analyzer. The reports were reviewed and signed by the LM. 4. A review of Sysmex Insight reports from May 2024 through January 2025 showed that the "Lot- to-Date" report for lot # 4115 included the three levels of hematology QC run from 05 /09/2024 through 05/31/2024. The next available "Lot-to-Date" report was for lot # 4171 and included the three levels of hematology QC run from 07/05/2024 through 09 /03/2024. There was no documentation that the laboratory had evaluated the hematology QC run between 06/01/2024 and 07/04/2024; and 5. The "Lot-to-Date" report for lot # 4227 included the three levels of hematology QC run from 08/27/2024 through 10/31/2024. The next available "Lot-to-Date" report was for lot # 4339 and included the three levels of hematology QC run from 12/12/2024 through 01/02/2025. There was no documentation that the laboratory had evaluated the hematology QC run between 11/01/2024 and 12/11/2024. 6. During an interview on 05/12/2025 at 6:20 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- PM, the LM confirmed that the laboratory failed to maintain all hematology QA records for a minimum of two years. 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 the proficiency testing (PT) procedure, review of PT records, and interview with the quality technical specialist (QTS), the laboratory failed to perform a self-evaluation or failed to document an investigation and