Guidelines for transfusion and immunohaematology laboratory practice

Scope

The aim of these guidelines is to provide guidance and direction for pathology laboratories responsible for providing transfusion services and undertaking immunohaematology testing, particularly in the prenatal and postnatal settings.

Adherence to standards, guidelines and documented policies and procedures is absolutely crucial to patient safety. Consequently, the laboratory must have a documented quality management system that describes the organisational structure, policies, procedures, processes and resources required to operate in accordance with safe and appropriate laboratory and clinical practice. In these settings, the provision of safe and appropriate practice requires:

• documentation and patient identification systems that minimise clerical errors and misidentification
• determination of a patient’s ABO and RhD group, and performance of an antibody screen to detect clinically significant red cell antibodies
• diagnosis and management of haemolytic disease of the fetus and newborn
• adherence to the stringent requirements necessary for the use of information and communications technology
• contingency plans for use when routine systems are not available – these should include manual systems to deal with loss of automation and the laboratory information system
• suitable quality control (QC) programs for reagents, techniques, equipment and personnel
• selection and provision of clinically safe and appropriate blood and blood products
• appropriate storage and handling of blood and blood products
• appropriate investigation of adverse effects of transfusion
• appropriate retention of records, data and documentation as required by regulatory bodies.

These guidelines reflect the broader transfusion and health-care environment that encompasses the requirements of national accreditation authorities, national blood services and other regulatory bodies. The laboratory should also be aware of any current complementary standards, requirements or guidelines; for example, those published by the National Pathology Accreditation Advisory Council, the Australian and New Zealand Society of Blood Transfusion, Standards Australia, Australia’s National Blood Authority, the Australian Commission on Safety and Quality in Health Care or the National Association of Testing Authorities.