Annex 7

Requirements for the timing of testing for hematopoietic progenitor cells – minimum standards and good practice

Please see explanatory notes below each table.

Terminology

HPC-A

Peripheral blood (stem cells, collected by apheresis)

HPC-M

Bone marrow (stem cells, collected from bone marrow)

MNC-A

Mononuclear cells (collected by apheresis, including starting material for advanced therapy medicinal product (ATMP) manufacture and donor lymphocyte infusions (DLIs))

HPC-CB

Umbilical cord blood

Mandatory

The test is either a regulatory requirement or deemed necessary to ensure regulatory requirements relating to the assessment of donor suitability are met to ensure donor and recipient protection

Discretionary

The test must be performed on certain donors/donations if indicated by medical, social or travel history

Recommended

This test is recommended by an advisory committee or a professional body, but is not a regulatory requirement

Optional

The test is not mandatory and done at the discretion of individual organisations or establishments. This also applies to situations where a mandatory test is repeated at the discretion of individual organisations or establishments.

Table A7.1: Allogeneic HPC-A and HPC-M

Test	Performed on	Requirement	Timing of test
Test ABO and RhD	Performed on Donor	Requirement Mandatory	Timing of test Prior to donation
Test Mandatory infectious markers	Performed on Donor	Requirement Mandatory	Timing of test Within 30 days prior to the donation episode
Test Mandatory infectious markers	Performed on Donor	Requirement Optional	Timing of test At the time of donation or within seven days post donation
Test Additional infectious markers (e.g. Malaria, WNV, T. cruzi)	Performed on Donor	Requirement Discretionary	Timing of test Prior to donation, depending on travel history or residential risk
Test CMV	Performed on Donor	Requirement Recommended	Timing of test At donor selection and within 30 days prior to the donation episode

Allogenic HPC-A and HPC-M

Test

ABO and RhD

Performed on

Donor

Requirement

Mandatory

Timing of test

Prior to donation

Test

Mandatory infectious markers

Performed on

Donor

Requirement

Mandatory

Timing of test

Within 30 days prior to the donation episode