Hematology Oncology Consultants Amedical Corp

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, competency assessment records, and interview with the laboratory technical consultant on August 27, 2025, at 3:10 p.m., the laboratory failed to assess competency of all 7 testing personnel. The findings include: 1. The laboratory performed CBC test using Micros60 automated instrument. The laboratory had 7 testing personnel. However, it did not assess competency of any of its testing person. Therefore, the accuracy of the patients' test results rendered by the incompetent testing personnel cannot be assured and may have potentially harmed patients. 2. The laboratory technical consultant on August 27, 2025, at 3:10 p.m., affirmed that the laboratory did not assess the competency of testing personnel. 3. The laboratory's testing declaration form, signed by the laboratory director on 8/5/2025, stated that the laboratory performed approximately 38,010 CBC tests, annually. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; 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 -- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, competency assessment records, and interview with the laboratory technical consultant on August 27, 2025, at 3:10 p.m., the laboratory director failed to ensure that only competent personnel are performing the teste. The findings include: See D5209. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, competency assessment records, and interview with the laboratory technical consultant on August 27, 2025, at 3:10 p.m., the laboratory technical consultant failed to evaluate the competency of testing personnel. The findings include: See D5209. -- 2 of 2 --

Summary Statement of Deficiencies D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, and interview with the laboratory personnel, it was determined that the laboratory failed to follow the manufacturer's instruction to perform instrument calibration based upon the performance specifications verified and established preciously. The findings included: a. The laboratory used ABX Micro 60 to perform complete blood cell count (CBC) including but not limited to White blood cell count (WBC) and automated WBC cell differentials, Red blood cell (RBC), hemoglobins, etc. b. The laboratory failed to follow the manufacturer instructions to perform calibration at the frequency of every 6 months in 2018 and 2019. c. The laboratory personnel affirmed (9/24/2019 @ 10:50 am) that the laboratory failed to perform ABX micro 60 instrument calibrations according to the manufacturer' instruction. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy 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 -- precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the instrument quality control (QC) data management, review of the laboratory's QC records, and interview with the laboratory personnel, it was determined that the laboratory failed to monitor overtime the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. The findings included: a. The laboratory performed three levels of QC, namely Low, Norm, and High, for its ABX Micro 60 hematology analyzer following the manufacturer's instructions. b. Review of the laboratory's Levey-Jennys (L-J) chart between 9/9/19 and 9/20/19 for WBC. c. The L-J chart showed 6 out of total of 8 fallen between 1SD and 2SD in a positive bias higher shift for Norm and High QC levels. d. The laboratory failed to detect its positive QC bias for WBC and failed to take actions to assess and evaluate the outcome. -- 2 of 2 --