Summary:
Summary Statement of Deficiencies D0000 A validation survey was completed on November 15, 2024, the laboratory was found out of compliance with the CLIA regulations. The condition not met: D5024 - 42 C.F. R. 493.1215 Condition: Hematology D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of procedures, the Center for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (CLIA) (Form 209), test records, and manufacturer's instructions, and interview with the Laboratory Director, the laboratory did not meet the requirements specified in 493.1251, 493.1252, and 493.1283. Findings include: 1. Procedures did not provide step-by-step instructions for evaluation of hematology results identified as 'Positive' by the Sysmex XN-430 analyzer and included instructions for specimen and result manipulation that were not applicable at this laboratory. See D5403. 2. Testing Personnel who processed patient samples did not evaluate 'Positive' flagged hematology results but physician staff responsible for evaluating the results prior to result reporting were not identified as testing personnel on Form 209. See D5411. 3. The laboratory did not document the identity of the person responsible for review of 'Positive' flagged hematology results. See D5787. D5403 PROCEDURE MANUAL CFR(s): 493.1251(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 -- 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)