Summary:
Summary Statement of Deficiencies 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 observation, record review, and interviews, the laboratory failed to establish policies and procedures to include imminently life-threatening values (refer to D5403), the laboratory failed to ensure laboratory procedures were approved, signed, and dated prior to patient testing using the Hemochron Signature Elite Activated Clotting Time (ACT) analyzer (refer to D5407), failed to follow the Hemochron Signature Elite Activated Clotting Time (ACT) manufacturer's instructions (refer to D5411), Based on observation, record review, and interview with the Testing Personnel, the laboratory failed to monitor room and refrigerator temperatures to ensure proper storage of reagents, controls, and for reliable operation of test systems (refer to D5413), failed to verify performance specifications for its Hemochron Signature Elite Activated Clotting Time (ACT) testing prior to using the test system for patient testing (refer to D5421), failed to perform Activated Clotting Time (ACT) control procedures each day of patient testing (refer D5445), and failed to transmit patient test data to the final test report destination (refer D5801). 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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)