Transcend Medical Group

Summary Statement of Deficiencies D0000 An unannounced onsite complaint survey was completed on 04/16/2025 for intake # TX00537504. The laboratory was found to be in compliance with the CLIA regulations for specialties/subspecialties surveyed for 42 CFR. The complaint was substantiated. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) evaluation form, review of the laboratory's instrument data, review of the laboratory's policy, and confirmed in interview, the laboratory failed to ensure PT results documented by the laboratory correlated with results submitted to the PT agency for one of one PT events in 2025 (2025 Event 1). Findings include: 1. Review of the API PT evaluation form determined the following results submitted by the laboratory were graded by the PT provider: 2025 Hematology / Coagulation - 1st Event: a. Sample ID: DXH-01 WBC: 7.3 x10^3/L RBC: 4.70 x10^6/L Hemoglobin: 14.3 g/dL Hematocrit: 41.1 % MCV: 87.5 fL MCH: 30.5 pg MCHC: 34.9 g/dL RDW- CV: 13.3 % RDW-SD: 48.3 % Platelet: 244 x10^3/L MPV: 8.4 fL Lymphocytes, %: 27.0 Monocytes, %: 0.0 Neutrophils, %: 69.4 Eosinophils, %: 3.6 Basophils, %: 0.0 b. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Sample ID: DXH-02 WBC: 2.3 x10^3/L RBC: 2.30 x10^6/L Hemoglobin: 6.5 g/dL Hematocrit: 19.1 % MCV: 83.9 fL MCH: 28.6 pg MCHC: 34.2 g/dL RDW-CV: 13.9 % RDW-SD: 48.1 % Platelet: 71 x10^3/L MPV: 9.6 fL Lymphocytes, %: 43.7 Monocytes, %: 0.2 Neutrophils, %: 44.7 Eosinophils, %: 11.4 Basophils, %: 0.00 c. Sample ID: DXH-03 WBC: 7.4 x10^3/L RBC: 4.70 x10^6/L Hemoglobin: 14.5 g/dL Hematocrit: 41.1 % MCV: 88.1 fL MCH: 31.0 pg MCHC: 35.3 g/dL RDW-CV: 13.5 % RDW-SD: 48.5 % Platelet: 240 x10^3/L MPV: 8.4 fL Lymphocytes, %: 27.1 Monocytes, %: 1.2 (Unacceptable) Neutrophils, %: 67.1 Eosinophils, %: 3.5 Basophils, %: 1.1 (Unacceptable) d. Sample ID: DXH-04 WBC: 18.0 x10^3/L RBC: 5.00 x10^6/L Hemoglobin: 17.4 g/dL Hematocrit: 48.7 % MCV: 97.5 fL MCH: 34.9 pg MCHC: 35.7 g/dL RDW-CV: 12.4 % RDW-SD: 49.9 % Platelet: 476 x10^3/L MPV: 8.1 fL Lymphocytes, %: 13.3 Monocytes, %: 0.4 Neutrophils, %: 78.4 Eosinophils, %: 7.8 Basophils, %: 0.1 e. Sample ID: DXH-05 WBC: 2.45 x10^3/L RBC: 2.30 x10^6/L Hemoglobin: 6.6 g/dL Hematocrit: 19.5 % MCV: 84.2 fL MCH: 28.5 pg MCHC: 33.7 g/dL RDW-CV: 13.9 % RDW-SD: 48.5 % Platelet: 79 x10^3/L MPV: 9.3 fL Lymphocytes, %: 45.4 Monocytes, %: 0.1 Neutrophils, %: 43.8 Eosinophils, %: 10.7 Basophils, %: 0.1 2. Review of the laboratory's instrument raw data in the PT records determined the laboratory failed to ensure PT results documented by the laboratory correlated with results submitted to the PT agency for one of one PT events in 2025 (2025 Event 1): a. Specimen ID: 031 Date/Time: 03/06 /2025 1503 hours Analyzer WBC: 7.41 x10^3/L Submitted result: 7.3 x10^3/L Analyzer RBC: 4.77 x10^6/L Submitted result: 4.70 x10^6/L Analyzer Hemoglobin: 14.76 g/dL Submitted result: 14.3 g/dL Analyzer Hematocrit: 41.8 % Submitted result: 41.1 % Analyzer MCV: 87.7 fL Submitted result: 87.5 fL Analyzer MCH: 30.9 pg Submitted result: 30.5 pg Analyzer MCHC: 35.3 g/dL Submitted result: 34.9 g/dL Analyzer RDW: 13.2 % Submitted result: 13.3 % Analyzer RDW-SD: 48.2 % Submitted result: 48.3 % Analyzer Platelet: 255.2 x10^3/L Submitted result: 244 x10^3/L Analyzer Lymphocytes: 28.09 % Submitted result: 27.0 % Analyzer Monocytes: 0.40 % Submitted result: 0.0 % Analyzer Neutrophils: 68.19 % Submitted result: 69.4 % Analyzer Eosinophils: 3.19 % Submitted result: 3.6 % Analyzer Basophils: 0.13 % Submitted result: 0.0 % b. Specimen ID: 032 Date/Time: 03/06 /2025 1504 hours Analyzer WBC: 2.47 x10^3/L Submitted result: 2.3 x10^3/L Analyzer RBC: 2.34 x10^6/L Submitted result: 2.30 x10^6/L Analyzer Hemoglobin: 6.63 g/dL Submitted result: 6.5 g/dL Analyzer Hematocrit: 19.7 % Submitted result: 19.1 % Analyzer MCV: 84.0 fL Submitted result: 83.9 fL Analyzer MCH: 28.3 pg Submitted result: 28.6 pg Analyzer MCHC: 33.7 g/dL Submitted result: 34.2 g/dL Analyzer RDW: 13.8 % Submitted result: 13.9 % Analyzer RDW-SD: 46.6 % Submitted result: 48.1 % Analyzer Platelet: 80.7 x10^3/L Submitted result: 71 x10^3 /L Analyzer MPV: 9.86 fL Submitted result: 9.6 fL Analyzer Lymphocytes: 42.58 % Submitted result: 43.7 % Analyzer Monocytes: 0.12 % Submitted result: 0.2 % Analyzer Neutrophils: 46.40 % Submitted result: 44.7 % Analyzer Eosinophils: 10.90 % Submitted result: 0.0 % c. Specimen ID: 033 Date/Time: 03/06/2025 1505 hours Analyzer WBC: 7.26 x10^3/L Submitted result: 7.4 x10^3/L Analyzer RBC: 4.71 x10^6/L Submitted result: 4.70 x10^6/L Analyzer Hematocrit: 41.5 % Submitted result: 41.1 % Analyzer MCH: 30.7 pg Submitted result: 31.0 pg Analyzer MCHC: 34.9 g/dL Submitted result: 35.3 g/dL Analyzer Platelet: 246.9 x10^3/L Submitted result: 240 x10^3/L Analyzer MPV: 8.32 fL Submitted result: 8.4 fL Analyzer Lymphocytes: 26.57 % Submitted result: 27.1 % Analyzer Monocytes: 0.04 % Submitted result: 1.2 % Analyzer Neutrophils: 70.08 % Submitted result: 67.1 % Analyzer Eosinophils: 3.31 % Submitted result: 3.5 % Analyzer Basophils: 0.00 % Submitted result: 1.1 % d. Specimen ID: 034 Date/Time: 03/06/2025 1507 hours Analyzer WBC: 18.05 x10^3/L Submitted result: 18.0 x10^3/L Analyzer RBC: 5.07 x10^6/L Submitted result: 5.00 x10^6/L Analyzer Hemoglobin: 17.63 g/dL Submitted -- 2 of 4 -- result: 17.4 g/dL Analyzer Hematocrit: 49.6 % Submitted result: 48.7 % Analyzer MCV: 97.9 fL Submitted result: 97.5 fL Analyzer MCH: 34.8 pg Submitted result: 34.9 pg Analyzer MCHC: 35.5 g/dL Submitted result: 35.7 g/dL Analyzer RDW: 12.0 % Submitted result: 12.4 % Analyzer RDW-SD: 50.1 % Submitted result: 49.9 % Analyzer Platelet: 494.6 x10^3/L Submitted result: 476 x10^3/L Analyzer MPV: 7.96 fL Submitted result: 8.1 fL Analyzer Lymphocytes: 13.68 % Submitted result: 13.3 % Analyzer Monocytes: 0.52 % Submitted result: 0.4 % Analyzer Neutrophils: 77.09 % Submitted result: 78.4 % Analyzer Eosinophils: 8.64 % Submitted result: 7.8 % e. Specimen ID: 035 Date/Time: 03/06/2025 1508 hours Analyzer RBC: 2.27 x10^6/L Submitted result: 2.30 x10^6/L Analyzer Hemoglobin: 6.41 g/dL Submitted result: 6.6 g/dL Analyzer Hematocrit: 19.2 % Submitted result: 19.5 % Analyzer MCV: 84.7 fL Submitted result: 84.2 fL Analyzer MCH: 28.2 pg Submitted result: 28.5 pg Analyzer MCHC: 33.4 g/dL Submitted result: 33.7 g/dL Analyzer RDW: 13.7 % Submitted result: 13.9 % Analyzer RDW-SD: 47.9 % Submitted result: 48.5 % Analyzer Platelet: 70.1 x10^3/L Submitted result: 79 x10^3/L Analyzer MPV: 8.78 fL Submitted result: 9.3 fL Analyzer Lymphocytes: 43.74 % Submitted result: 45.4 % Analyzer Monocytes: 0.24 % Submitted result: 0.1 % Analyzer Neutrophils: 44.24 % Submitted result: 43.8 % Analyzer Eosinophils: 11.58 % Submitted result: 10.7 % Analyzer Basophils: 0.20 % Submitted result: 0.1 % 3. Testing person-1 (as listed on the CMS-209 form) confirmed the findings in an interview on 04/16/2025 at 1310 hours in the office. Key: WBC - white blood cell RBC - red blood cell MCV - mean corpuscular volume MCH - mean corpuscular hemoglobin MCHC - mean corpuscular hemoglobin concentration RDW-CV - red cell distribution width, coefficient of variation RDW-SD - red cell distribution width, standard deviation MPV - mean platelet volume x10^3/L - thousand per microliter x10^6/L - million per microliter g /dL - grams per deciliter % - percent fL - femtoliter pg - picogram CMS - Centers for Medicare and Medicaid Services D5785