13.1: Scope

These specifications provide guidance on the tests required for investigations performed on patient samples in red cell immunohaematology (RCI) laboratories in UK Blood Transfusion Centres. These include pre-transfusion and compatibility testing, tests associated with supporting the prevention and treatment of Haemolytic Disease of the Fetus and Newborn (HDFN), assessment of fetomaternal haemorrhage, and titration studies supporting ABO mismatched transplant.

Extended testing of blood donors other than in the above contexts is covered in Chapter 12.

It is assumed that RCI laboratories comply with the following guidelines:

• Guideline for Blood Grouping and Antibody Testing in Pregnancy (British Committee for Standards in Haematology, BCSH)¹
   
• The Specification and Use of Information Technology (IT) Systems in Blood Transfusion Practice (BCSH)²
   
• Guidelines for Pre-transfusion Compatibility Procedures in Blood Transfusion Laboratories (BCSH)³
   
• The Estimation of Fetomaternal Haemorrhage (BCSH)⁴

And also comply with:

• UKAS Medical Laboratories accreditation (ISO15189)⁵
   
• The Blood Safety and Quality Regulations 2005⁶

Participation in relevant NEQAS BTLP schemes is recommended. Exercise results should be reviewed and any findings acted upon.

This chapter is intended to cover practice in areas not included in published UK guidelines at the time of writing. Where practice differs either from published guidance or this chapter, laboratory managers should formally document the reasons for doing so and assess the associated risk.