Annex 7: Requirements for the timing of testing for hematopoietic progenitor cells – minimum standards and good practice

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.

Please see the explanatory notes below each table.

Table A7.1: Allogeneic HPC-A and HPC-M
Test	Performed on	Requirement	Timing of test
ABO and RhD [1]	Donor	Mandatory	Prior to donation
Mandatory infectious markers [2]	Donor	Mandatory	Within 30 days prior to the donation episode
Mandatory infectious markers [2]	Donor	Optional	At the time of donation or within 7 days post donation
Discretionary additional infectious markers [3]	Donor	Discretionary	Prior to donation, depending on travel history or residential risk
CMV	Donor	Recommended	At donor selection, and within 30 days prior to the donation episode
Toxoplasma	Donor	Recommended	Within 30 days prior to the donation episode
EBV	Donor	Recommended	Within 30 days prior to the donation episode
Pregnancy test [4]	Donor	Discretionary	7 days prior to starting donor mobilisation regime (G-CSF), and (as applicable) within 7 days prior to the initiation of the recipient's preparative regime
Haemoglobinopathies [5]	Donor	Discretionary	At the time of donor assessment
Bacteriology testing	Product (processed)	Optional	Pre-processing
Bacteriology testing	Product (processed)	Mandatory	Post-processing
Bacteriology testing	Product (fresh)	Mandatory	Post collection
Bacteriology testing	Product (fresh)	Mandatory	Immediately before every collection for HPC-A; prior to first donation for HPC-M

Notes on Table A7.1

Using two independently collected samples; different needlesticks.
See chapter 9.2. Testing the donor once within the specified timescale is mandatory, repeating the test is optional.
Align with Donor Selection Guidelines.
Applies to all donors of childbearing potential.
Applies to those donors thought to be at risk of sickle cell disease and compound haemoglobinopathies.

Table A7.2: Autologous HPC-A and HPC-M
Test	Performed on	Requirement	Timing of test
ABO and RhD [1]	Donor	Optional	Prior to donation
Mandatory infectious markers [2]	Donor	Mandatory	Within 30 days prior to the donation episode
Mandatory infectious markers [2]	Donor	Optionl	At the time of donation or within 7 days post donation
Discretionary additional infectious markers [3]	Donor	Discretionary	Prior to donation, depending on travel history or residential risk
Pregnancy test [4]	Donor	Discretionary	7 days prior to starting donor mobilisation regime (G-CSF), and, as applicable, within 7 days prior to the initiation of the recipient's preparative regime
CMV [5]	Donor	Optional	Within 30 days prior to the donation episode
Toxoplasma [5]	Donor	Optional	Within 30 days prior to the donation episode
EBV [5]	Donor	Optional	Within 30 days prior to the donation episode
Haemoglobinopathies [6]	Donor	Discretionary	At the time of donor assessment
Bacteriology testing	Product (processed)	Optional	Pre-processing
Bacteriology testing	Product (processed)	Mandatory	Post-processing
Bacteriology testing	Product (fresh)	Mandatory	Post collection
FBC	Donor	Mandatory	Immediately before every collection for HPC-A; prior to first donation for HPC-M

Notes on Table A7.2

Due to autologous nature of product, not essential.
April 2023: Sample timing currently under review by HTA. See chapter 9.2. Testing the donor once within the specified timescale is mandatory, repeating the test is optional.
In selected circumstances based on individual risk assessment, testing may be requested/required. Align with Donor Selection Guidelines.
Applies to all donors of childbearing potential.
In selected circumstances based on individual risk assessment, testing may be requested/required if indicated by donor history.
Applies to those donors thought to be at risk of sickle cell disease and compound haemoglobinopathies.

Table A7.3: Autologous and allogeneic MNC-A
Test	Performed on	Requirement	Timing of test
ABO and RhD [1]	Donor (allogenic)	Mandatory	Prior to donation
ABO and RhD [2]	Donor (autologous)	Optional	Prior to donation
Mandatory infectious markers [3]	Donor (allogenic and autologous)	Mandatory	At the time of donation or within 7 days post donation
Discretionary additional infectious markers [4]	Donor (allogenic and autologous)	Discretionary	Prior to donation, depending on travel history or residential risk
CMV	Donor (allogeneic)	Recommended	At donor selection, and within 30 days prior to the donation episode
CMV [5]	Donor (autologous)	Optional	Within 30 days prior to the donation episode
Toxoplasma	Donor (allogeneic)	Recommended	Within 30 days prior to the donation episode
Toxoplasma [5]	Donor (autologous)	Optional	Within 30 days prior to the donation episode
EBV	Donor (allogeneic)	Recommended	Within 30 days prior to the donation episode
EBV [5]	Donor (autologous)	Optional	Within 30 days prior to the donation episode
Pregnancy test [6]	Donor (allogeneic and autologous)	Discretionary	Within 7 days prior to collection
Haemoglobinopathies [7]	Donor	Discretionary	At the time of donor assessment
Bacteriology testing	Product (processed)	Optional	Pre-processing
Bacteriology testing	Product (processed)	Mandatory	Post-processing
Bacteriology testing	Product (fresh)	Mandatory	Post collection
Full blood count	Donor	Mandatory	Immediately before each collection

Notes on Table A7.3

Using two independently collected samples; different needlesticks.
Due to autologous nature of product, not essential.
See chapter 9.2. If MNC are collected at the same time as HPC, the same time specified in Table A7.1 and Table A7.2 apply.
Align with Donor Selection Guidelines. For autologous donors in selected circumstances based on individual risk assessment, testing may be requested/required.
In selected circumstances based on individual risk assessment, testing may be requested/required if indicated by donor history.
Applies to all donors of childbearing potential.
Applies to those donors thought to be at risk of sickle cell disease and compound haemoglobinopathies.

Table A7.4: HPC-CB
Test	Performed on	Requirement	Timing of test
ABO and RhD	Product	Mandatory	Prior to cryopreservation
Mandatory infectious markers [1]	Mother	Mandatory	At the time of donation or within 7 days post donation
Mandatory infectious markers [2]	Product	Recommended	Prior to release
Discretionary additional infectious markers [3]	Mother	Discretionary	0 to +7 days
Discretionary additional infectious markers [3]	Product	Discretionary	Prior to release, where applicable
CMV	Mother	Recommended	0 to +7 days
CMV	Product	Recommended	Prior to release
Toxoplasma	Mother	Recommended	0 to +7 days
EBV	Mother	Recommended	0 to +7 days
Haemoglobinopathies [4]	Product	Discretionary	Prior to release
Bacteriology testing	Product	Mandatory	Post processing, prior to cryopreservation
FBC	Product	Mandatory	Between the end of collection and pre-processing

Notes on Table A7.4

See chapter 9.2.
Testing of the maternal sample at the time of donation, including NAT, may be used as a surrogate marker for the product. Testing of the product is recommended but not mandatory.
Depending on travel history or residential risk. Align with Donor Selection Guidelines.
Sample from product or neonatal screen.

Last updated on 4 September 2023