Summary:
Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review the laboratory's procedure manual; patients' test reports; and interview with the laboratory director, the laboratory failed to have a written or electronic request for patient testing from an authorized person for its Activated Clotting Time test. Findings: 1. Review of the laboratory's procedure manual revealed that there were no written procedures that described how tests are ordered. 2. Review of 5 patients test reports revealed that there was no documentation to show that the tests were ordered from an authorized person for 5 of 5 reviewed. 3. On December 7, 2020 at 10:30 AM, the laboratory director confirmed the surveyor's findings. 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)