Preparing Surrogate Abnormal Quality Control Samples for Platelet Function Studies and Viscoelastic Testing.

In the United States, published options for clinical laboratories to perform quality control (QC) procedures less stringent than the regulatory requirements (Clinical and Laboratory Improvement Act, CLIA) based on risk assessment, although the laboratory must perform to manufacturer's minimum requirements. The US requirements for internal quality control requires at least two levels of control material every 24 h of patient testing. For some coagulation testing, the recommended quality control may be a normal sample or commercial controls that do not address all reporting components of the test. Additional circumstances and difficulties in achieving this minimum QC requirement can be due to either (1) nature of the sample type (i.e., whole blood sample requirements), (2) lack of commercial or suitable control material, or (3) unusual or rare samples. The purpose of this chapter is to provide provisional guidance for laboratory sites to prepared samples to verify the performance of reagents and testing performance of platelet function studies and viscoelastic measurements.