East Coast Medical, Pllc

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records for 2024 and 2025, and interview with the Technical Consultant (TC) 10/01/2025, the Laboratory Director (LD) failed to specify in writing the duties and responsibilities for the Clinical Consultant (CC) involved in the daily operation of the laboratory. Findings: Review of personnel records revealed the absence of a job description for the CC. During interview at approximately 11:13 a.m., the TC confirmed no position description available for the CC. 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 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 policies and procedures and review of 2020, 2021, and 2022 MLE (Medical Laboratory Evaluation) and 2023 AAB (American Association of Bioanalysts) MLE proficiency testing records 6/5/23, the laboratory failed to test proficiency samples in the same manner as patient specimens are routinely tested for 10 of 10 events reviewed. Findings: Review of the laboratory's "Proficiency Testing" procedure revealed "... PROCEDURE: ... 4. Proficiency test samples will be tested in exactly the same manner as patient samples are tested. ... b. Samples will only be repeated (e.g. with panic values) if a patient sample would have been repeated under the same circumstances. ..." Review of the Medonic M-series procedure revealed "... CRITICAL VALUES: Critical values must be rerun to verify before reporting. ..." The procedure listed critical values for WBC (white blood cell count), hemoglobin, and platelets. Review of 2020, 2021, 2022, and 2023 proficiency testing records revealed proficiency samples were not rerun as required when critical values were obtained as specified in the laboratory's procedures. Examples: 1. MLE 2020 - 3 of 3 test events (M1, M2, M3) had critical values for hemoglobin that were not repeated; 2. MLE 2021 - 3 of 3 test events (M1, M2, M3) had critical values for hemoglobin that were not repeated; 3. MLE 2022 - 3 of 3 test events (M1, M2, M3) 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 -- had critical values for hemoglobin that were not repeated; 4. AAB MLE 2023 - 1 of 1 test events (M1) had critical values for hemoglobin that were not repeated. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2020, 2021, and 2022 MLE (Medical Laboratory Evaluation) and 2023 AAB (American Association of Bioanalysts) MLE proficiency testing records 6/5/23, the laboratory failed to ensure all TP (testing personnel) participated in proficiency testing for 8 of 10 testing events. Findings: Review of the laboratory's "Proficiency Testing" procedure revealed "PROCEDURE: 1. Proficiency testing will be rotated among the techs so that everyone working in a lab discipline participates in the testing throughout the year. ..." Review of 2020, 2021, 2022, and 2023 proficiency testing records revealed: 1. MLE 2020 - TP #2 tested all samples in 2 of 3 events (M2 and M3); 2. MLE 2021 - TP #2 tested all samples in 3 of 3 events (M1, M2, M3); 3. MLE 2022 - TP #2 tested all samples in 2 of 3 events (M1 and M2); 4. AAB MLE 2023 - TP #2 tested all samples in 1 of 1 events (M1). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)