Logan County Health Services

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 policy "Automated Hematology Analyzer For CBC" and interview with General Supervisor #2 (GS#2), the laboratory failed to ensure the test report included correct normal ranges as determined by the laboratory "Automated Hematology Analyzer For CBC" policy at time of survey. Findings: 1. Review of the patient reports from the Laboratory Information System (LIS), Orchard, revealed 16 out of 22 parameters for normal ranges did not correctly match those reference ranges for the complete blood count (CBC) test in the laboratory "Automated Hematology Analyzer For CBC" procedure manual. LIS (Orchard) patient report: (Male Adult >18 y/o) RBC 3.99-5.66 10^6/UL HGB 12.8-16.8 g/dL HCT 38.7-52.5 % MCV 86.0-100.0 fL MPV 6.0-10.0 fL MCH 27.5-33.5 pg MCHC 31.3-36.0 g/dL LYMPH% 20.0-40.0 % MONO% 1.0-6.0 % BASO% 0.0-3.0 % (Female Adult >18 y/o) RBC 3.99-5.76 10^6/UL HGB 11.7-16.7 g /dL HCT 38.7-52.5 % MCV 86.0-100.0 fL MPV 6.0-10.0 fL MCH 27.5-33.5 pg MCHC 31.3-36.0 g/dL LYMPH% 20.0-40.0 % MONO% 1.0-6.0 % BASO% 0.0-3.0 % Procedure Manual Parameters: (Male Adult >18 y/o) RBC 4.32-5.84 10^6/UL HGB 13.5-16.8 g/dL HCT 41.2-52.4 % MCV 84-100 fL MPV 9-12 fL MCH 27.6- 33.2 pg MCHC 31.0-36.0 g/dL LYMPH% 15.0-45.0 % MONO% 4.0-11.0 % BASO% 0.0-2.0 % (Female Adult >18 y/o) RBC 3.92-5.58 10^6/UL HGB 11.7-16.0 g /dL HCT 38.3-47.2 % MCV 83-103 fL MPV 9-12 fL MCH 26.9-32.9 pg MCHC 31.5- 36.0 g/dL LYMPH% 15.0-45.0 % MONO% 4.0-11.0 % BASO% 0.0-2.0 % 2. Interview with General Supervisor #2 on 3/12/2024 at 14:00 a.m. confirmed, the laboratory failed to ensure the correct reference ranges approved in the "Automated 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 -- Hematology Analyzer For CBC" procedure manual were in correlation with the LIS (Orchard) patient report. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a lack of available documentation and confirmed during interview with technical consultant #1 (TC#1) and technical consultant #2 (TC#2), the laboratory failed to have a Complete Blood Count (CBC) procedure for the Sysmex XN 550 analyzer approved, signed, and dated by the laboratory director before use. Findings: 1. Upon review of the laboratory procedures in hematology, the laboratory director did not approve, sign, and date a laboratory procedure for CBC with regard to the Sysmex XN 550 analyzer at time of survey. 2. Interview with TC#1 and TC#2 on June 21, 2022 at 11:15 a.m. confirmed, the laboratory failed to have a CBC procedure in hematology for the Sysmex XN 550 approved, signed, and dated by the laboratory director before use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --