Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for 2024/2025 and interview with the laboratory director (LD), the laboratory failed to provide attestation documentation for four of twelve PT testing events in 2024. Findings: 1. Review of PT records for 2024 showed the laboratory could not provide attestation records for testing personnel and the laboratory director to show routine integration of samples into the patient workload for the following proficiency testing events: 2024 Chemistry- first event 2024 Hematology/Coagulation-first event 2024 Chemistry-second event 2024 Hematology-third event 2. Interview with the LD on January 20, 2026 at 11:30 AM confirmed the laboratory could not provide PT testing events attestation records for four PT testing events in 2024. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. 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 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for 2024/2025 and interview with the laboratory director (LD), the laboratory failed to maintain copies of all PT records including raw data of PT test results for three of twelve PT testing events in 2024 and 2025. Findings: 1. Review of PT records for 2024 showed the laboratory could not provide raw data of PT test results for the following proficiency testing events: 2024 Hematology/Coagulation-first event 2024 Chemistry-second event 2. Review of PT records for 2025 showed the laboratory could not provide raw data of PT test results for the following proficiency testing event: 2025 Chemistry-third event 3. Interview with the LD on January 20, 2026 at 11:30 AM confirmed the laboratory could not provide raw data of PT test results for three PT testing events in 2024 and 2025. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of Sysmex XN550 calibrations, review of the Sysmex XN550 quality control (QC), review of Triage chemistry QC, and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to perform calibration verification on the Sysmex XN550 hematology analyzer in 2024 to date January 21, 2026 (Refer to D5437); and the laboratory failed to provide documentation of two control materials of different concentrations each day of patient testing for complete blood count (CBC), differential and creatine kinase-myocardial band (CK/MB) and troponin (Refer to D5447). D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of Sysmex XN550 hematology analyzer's calibration records and interview with the laboratory director, the laboratory failed to perform calibration -- 2 of 5 -- verification on the Sysmex XN550 hematology analyzer in 2024 to date January 21, 2026. Findings: 1. Review of 2024, 2025, and to date January 20, 2026 calibration records for the Sysmex XN550 hematology analyzer showed the laboratory failed to perform a calibration verification every six months in 2024, 2025 and to date January 20, 2026 for the analytes: white blood cell, red blood cell, hemoglobin, hematocrit and platelet. 2. The laboratory was performs 1422 complete blood counts annually. 3. Interview with the laboratory director on January 20, 2026 at 10:00 AM confirmed the laboratory failed to perform calibration verification every six months for calibration of the Sysmex XN550 hematology analyzer. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on review of Sysmex XN550 quality control (QC), triage QC and interview with the lab director, the laboratory failed to provide documentation of two control materials of different concentrations each day of patient testing for complete blood count (CBC), differential and creatine kinase-myocardial band (CK/MB) and troponin. Findings: 1. Review of Sysmex XN550 hematology QC showed the laboratory could not provide QC each day of patient testing for white blood cell, red blood cell, hemoglobin, hematocrit, platelet count and differentials from January 2024 to date January 20, 2026. 2. The laboratory performs 1422 CBC's annually. 3. Review of Triage chemistry QC showed the laboratory could not provide QC each day of patient testing for CK/MB and troponin from January 2024 to date January 20, 2026. 4. The laboratory performs 196 CK/MB and troponin's annually. 5. Interview with the laboratory director on January 20, 2026 at 11:30 AM, confirmed the laboratory failed to provide documentation of two control materials of different concentrations each day of patient testing for CBC's, differential, CK/MB and troponin. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT), review of quality assessment program, review of testing personnel (TP) training, the laboratory failed to meet the condition of laboratory director (LD). The LD failed to ensure three of twelve PT testing events were reviewed by appropriate staff to evaluate, identify problems requiring