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International Council for Standardization in Haematology Recommendations for Hemostasis Critical Values, Tests, and
Robert C Gosselin1, Dorothy Adcock2, Akbar Dorgalaleh3
1Thrombosis and Hemostasis Center, University of California, Davis Health System, Sacramento, California.
Insights
This guidance helps clinical laboratories identify high-risk hemostasis (coagulation) tests and establish critical result thresholds. It provides a framework for developing laboratory policies to improve patient safety in hemostasis testing.
Area of Science:
- Clinical Laboratory Science
- Hematology
- Hemostasis and Thrombosis
Background:
- The International Council for Standardization in Haematology (ICSH) develops guidance for clinical laboratories.
- Hemostasis testing is crucial for patient diagnosis and management.
- Standardized protocols for critical results are needed to ensure patient safety.
Purpose of the Study:
- To provide laboratory guidance for identifying hemostasis tests with potential patient risk.
- To define critical result thresholds and reporting mechanisms.
- To assist in developing laboratory policies for critical values in hemostasis testing.
Main Methods:
- Development of guidance by an ad hoc committee of international clinical and laboratory experts.
- Recommendations based on published data, expert opinion, and good laboratory practice.
- Consideration of factors influencing critical test identification and policy development.
Main Results:
- Identification of hemostasis tests with potential patient risk.
- Establishment of critical result thresholds.
- Guidelines for reporting, documentation, and policy development.
Conclusions:
- The ICSH guidance provides a framework for clinical laboratories to manage critical hemostasis test results.
- Implementation of these recommendations can enhance patient safety.
- Laboratories should adapt the guidance to their specific regional and institutional contexts.
Abstract:
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.
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