Summary:
Summary Statement of Deficiencies D5547 HEMATOLOGY CFR(s): 493.1269(c)(d) (c) For manual coagulation tests-- (c)(1) Each individual performing tests must test two levels of control materials before testing patient samples and each time a reagent is changed; and (c)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of quality control procedures, observation of the Stago Start coagulation test system, and interview with the technical consultant, each testing person performing Prothrombin Time tests did not test two levels of control materials before testing patient samples. Findings include: 1. Review of the "Types of Controls Summary" procedure shows coagulation controls, normal and abnormal, are to be run each day of patient Prothrombin Time testing and prior to using freshly made Neoplastine for patient testing. 2. Observation of the coagulation system in the laboratory on July 29, 2019 at 12:00 PM showed the laboratory uses a manual method, the Stago Start analyzer, for Prothrombin Time testing. 3. Interview with the technical consultant on July 29, 2019 at 12:15 PM confirmed the Stago Start coagulation analyzer is a manual testing method for Prothrombin Time testing. Further interview revealed the laboratory does not batch prothrombin time testing and confirmed each testing person did not test control materials before testing patient samples. D5785