Summary:
Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(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 review of approved reference ranges in the laboratory "Reference Range" procedure manual and interview with the Laboratory Director (LD), General Supervisor #2 (GS#2) and Testing Personel #5 (TP#5) the laboratory failed to ensure the test report included correct normal ranges as determined by the laboratory "Reference Range" policy at time of survey. Findings: 1. Review of the patient reports from the Laboratory Information System (LIS) revealed 20 out of 21 parameters for normal ranges did not correctly match those reference ranges for the complete blood count (CBC) test in the laboratory "Reference Range" procedure manual. LIS patient report: (Female Adult >21 Y/o) (Male Adult >21 y/o) WBC 4.8-10.80 10^3/uL Unisex RBC 4.0-5.21 10^6/uL 4.8-10.8 10^6/uL HGB Range OK 13.5-17.5 g/dL HCT 36.0-46.0% 40.0-54.0% MCV 80.0-100.0 fL Unisex MCH 26.0-34.0 pg Unisex MCHC 32.0-36.0 g/dL Unisex PLT 150-350 10^3/uL Unisex NEUT% 55.0-70.0 % Unisex LYM% 20.0-40.0 % Unisex MON% 2.0-8.0 % Unisex EOS% 1.0-4.0 % Unisex BAS% 0.5-1.0 % Unisex Neut# 1.4-6.5 10^3/uL Unisex Lymph# 1.2-3.4 10^3 /uL Unisex Mono# 0.1-0.6 10^3/uL Unisex Eos# 0.0-0.7 10^3/uL Unisex Baso# 0.0- 0.2 10^3/uL Unisex Procedure Manual Parameters: (Female Adult >21 y/o) (Male Adult >21 y/o) WBC 3.6-10.8 10^3/uL Unisex RBC 4.00-5.10 10^6/uL 4.00-5.90 10^6/uL HGB Range OK 13.27-17.4 g/dL HCT 34-48 % 38-53 % MCV 85-103 fL Unisex MCH 28-33 pg Unisex MCHC 30-35 g/dL Unisex PLT 170-347 10^3/uL Unisex NEUT% None Listed LYM% None Listed MON% None Listed EOS% None Listed BAS% None Listed Neut# None Listed Lymph# None Listed Mono# None Listed Eos# None Listed Baso# None Listed 2. Interview with GS#2 and TP#5 on 7/12 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 -- /2022 at 10:35 a.m. confirmed, the laboratory failed to ensure the correct reference ranges approved in the "Reference Range" procedure manual were in correlation with the LIS patient report. -- 2 of 2 --