International Council for Standardization in Haematology Recommendations for Hemostasis Critical Values, Tests, and Reporting.

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH), the aim of which is to provide hemostasis-related guidance documents for clinical laboratories. The current ICSH document was developed by an ad hoc committee, comprising an international collection of both clinical and laboratory experts. The purpose of this ICSH document is to provide laboratory guidance for (1) identifying hemostasis (coagulation) tests that have potential patient risk based on analysis, test result, and patient presentations, (2) critical result thresholds, (3) acceptable reporting and documenting mechanisms, and (4) developing laboratory policies. The basis for these recommendations was derived from published data, expert opinion, and good laboratory practice. The committee realizes that regional and local regulations, institutional stakeholders (e.g., physicians, laboratory personnel, hospital managers), and patient types (e.g., adults, pediatric, surgical) will be additional confounders for a given laboratory in generating a critical test list, critical value thresholds, and policy. Nevertheless, we expect this guidance document will be helpful as a framework for local practice.

Informations de copyright

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Déclaration de conflit d'intérêts

R.C.G. involved with expert testimony for dabigatran and rivaroxaban testing, served on advisory committees for Novo Nordisk and Roche Diagnostics, served as a consultant for Diagnostic Grifols, and received honoraria from Siemens Healthcare Diagnostics. D.A. received speaker's honorarium from Siemens Healthcare Diagnostics, serves as a consultant to Novo Nordisk and Bayer Pharmaceuticals. J.M.P. provided consulting for Horiba Medical and Snibe Co., Ltd. A.D., E.J.F., G.L., I.R., and V.S. report no disclosures.