Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on 08/21/2025. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor accuracy of patient test reference ranges within the procedure when compared to reference ranges in patient rest reports for year 2023, 2024 and 2025 for 6 of 6 patient test reports. Findings included: Record review on 08/21/2025 at 3:30 p.m. revealed reference ranges in 6 patient test reports that did not match reference ranges in the laboratory's procedure for Red Blood Cell Count (RBC), Hemoglobin (HGB), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Platelets (PLT), Neutrophil Count (NE#), and Neutrophil Percentage (Neutrophil %). a.) Patient test reports had the following "Ref. Range" for the above analytes: RBC 4-6.1 HGB 12-18 HCT 36-52 MCV 80.9-99 PLT 130-440 NE# 2.2-4.8 NE% 45-80 b.) Laboratory ranges in the procedure titled "Park Duvalle Clinic" for "Complete Blood Count" had the following "Reference Range" for the above analytes: RBC 4.5-5.9 HGB 13.5-17.5 HCT 41-53 MCV 80-94 PLT 140- 440 NE% During an interview on 08/21/2025 at 3:15 p.m. in the Laboratory Director's (LD) office, located within the laboratory; the Technical Consultant (TC) and the Laboratory Director (LD) were asked for any updated documentation within their laboratory's procedure that would match the reference ranges on the patient test reports for Red Blood Cell Count (RBC), Hemoglobin (HGB), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Platelets (PLT), Neutrophil Count (NE#), and 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 -- Neutrophil Percentage (Neutrophil %). No documentation was provided. This confirmed the findings. -- 2 of 2 --