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WMDA Donor Medical Suitability Recommendations

Disclaimer

These guidelines exist as an aid to organisations in assessing the medical suitability of their (maternal) donors. Please be reminded that these guidelines are not intended to supersede local laws or requirements of national legislative bodies.

About the WMDA donor medical suitability guidelines

Guidance provided by the World Marrow Donor Association (WMDA) aims to provide minimum standards by which potential donors should be assessed.

The guidance below reflects the consensus opinion provided by the WMDA donor medical suitability committee. The purpose of this guidance is to provide globally harmonised medical assessment criteria which simultaneously protect the interest of donors whilst ensuring the safety of cellular products across international boundaries.

Disclaimer

These guidelines exist as an aid to organisations in assessing the medical suitability of their potential donors. Please be reminded that these guidelines are not intended to supersede local laws or requirements of national legislative bodies.

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title	About the WMDA donor medical suitability guidelines

Guidance provided by the World Marrow Donor Association (WMDA) aims to provide minimum standards by which potential donors should be assessed. The WMDA guidance reflects the consensus opinion of the WMDA Donor Medical Suitability Committee. The purpose of this guidance is to provide globally harmonised medical assessment criteria which simultaneously protect the interest of donors whilst ensuring the safety of cellular products across international boundaries.

Whilst this WMDA guidance is not specifically intended for related donors, those involved with the medical assessment of related donors should consider these recommendations.

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title	How donor medical suitability is assessed

Two key concepts govern the assessment of donor health, namely restrictive criteria for donor risk and more permissive criteria for recipient risk

Donor risk

Donation of

hematopoietic

haematopoietic stem cells (HSC) is an act of altruism, and may be to a recipient in a different country, with quite different moral, cultural and religious values.
Whilst it is recognised that the process of donation carries a small but unavoidable risk of harm to the donor, it is both the moral and legal responsibility of donor registries and donor centres to minimise any avoidable risk. This includes medical conditions that may increase the risk of harm to the donor before, during, and after the collection of HSC.
For this reason, medical criteria governing conditions that may increase donor risk are necessarily stringent, and certainly more so than would be the case if the individual were undergoing a procedure for therapeutic benefit.
In many cases it is difficult to establish a rigorous evidence base as justification for the criteria. In such cases, expert opinion of the underlying physiology of disease will be sought, and combined with knowledge of the known physiological changes associated with donation, as well as experience gained through several decades of HSC donor follow-up and adverse event reporting.
In general, if there is any doubt about the safety of the donor in the presence of a particular medical condition, it will be recommended that any donor with that condition be prevented from donating.

Recipient risk

By contrast, our recommendations regarding conditions that may put the recipient at risk are more lenient.
For many patients, an unrelated donor HSC transplant represents the only possibility of disease cure or long-term remission. Because of the diverse nature of HLA tissue-types, many patients will have a limited number of potentially matched donors. In such cases, donor medical conditions that may present a risk to the recipient alone should be reported to the transplant centre,

who are Jacob autoreactive Procedure for creating and reviewing donor medical suitability committeeTo create these initial guidelines, individual members of the working group were allocated criteria to write, which were then disseminated for review to the entire group. Consensus criteria were then agreed following consideration of all comments made.The individual the committee chair/designate and reviewed by committee members. Comments and justifications for the committee website

Please email Hung Yang hyang@abmdr.org.au with your request or comments. Please include your name and affiliation as we will be unable to review anonymous requests.

Related donors

Whilst this WMDA guidance is not specifically intended for related donors, those involved with the medical assessment of related donors should consider these recommendations.

Add your question or recommendation at the question section or send an email to mail@wmda.info.

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title	WMDA Recommendations for assessing donor medical suitability

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title	Table

1 minimum obtained recruitmentTable 2 - Recommended minimum medical

and lifestyle information at enrolment

Importance	Medical history	Examples of relevant conditions
Recommended	Transmissible and incurable infections with potential risk for the donor	HIV; HTLV
	Serious/inherited blood disorders	Sickle cell disease; thalassaemia major; inherited bleeding disorders
	History of major transplant	Organ; haemopoietic stem cell
	Known cardiovascular disease	Stroke; heart attack
Optional	Cancer	Haematological malignancies
	Autoimmune disease	Especially serious/systemic conditions like multiple sclerosis; systemic lupus erythematosus
	Transmissible infections	Hepatitis B, hepatitis C, syphilis, Chagas disease, malaria
	Potentially transmissible infections	CJD, tuberculosis
	Height and weight	BMI may reflect likely venous access
	General medical history	Past or current medical problems can predict fitness for donation and/or risk to a recipient
	Current medications	Lithium; teratogenic drugs
	Allergies	Especially allergens that may be encountered during donation – latex; anaesthetic

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title	Table 2 - Recommended minimum medical and lifestyle information obtained at confirmatory/verification typing stage

Minimum donor medical and lifestyle information requested at confirmatory/verification typing stage

Medical history	Examples of relevant conditions or questions
Cancer
Autoimmune disease	Ankylosing spondylitis; Crohn’s disease; ulcerative colitis; myasthenia gravis; rheumatoid arthritis; sarcoidosis; SLE; multiple sclerosis; scleroderma/CREST. Any other autoimmune condition
Infectious diseases, including being a sexual partner of an infected individual	HIV, Hepatitis B, Hepatitis C, HTLV, syphilis
Infectious diseases, others	CJD (including familial and exposure risk, e.g. neurosurgery, use of pituitary hormone), Chagas disease, tuberculosis, malaria
Back problems	Any acute or chronic back complaint, including cause, investigations, duration, medication and impact on activities of daily living
Hypertension	Most recent blood pressure readings; medications; degree of control
Cardiac disease	Coronary artery disease; evidence of valve disease, e.g. murmur; arrhythmia
Asthma	Degree of control; medications; use of oral steroids; hospital admissions; intensive care admissions/ventilation
Epilepsy	Medications; date of last seizure
Pregnancy	Number of pregnancies, including miscarriage; current/recent pregnancies; breastfeeding.
Blood transfusion	Receipt of a blood transfusion. Ask year and place of transfusion.
Any other medical history	The potential donor should be asked if they have any other past or current medical problems
Height and weight
High risk sexual behaviour	As defined by the registry’s national competent authority
Non-prescription parenteral drug use
Alcohol consumption
Tattoo, acupuncture or body piercing	When and where. Establish if at an establishment registered according to national regulations
Current medications
Allergies

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title	Table 3 - Recommended medical assessment at work-up - updated!

Medical assessment at work-up

Medical history as per Table 2, plus:
Travel history	Identify travel to areas with endemic malaria and/or arboviruses such as West Nile virus; dengue; Zika
Place of birth	Identify donors born in an area with endemic Chagas’ disease
Sexual history	Identification of high-risk sexual behaviour, including within groups associated with a higher prevalence of blood-borne infections
Examination	General (including height and weight); cardiovascular (including blood pressure); respiratory; gastrointestinal; neurological
Laboratory investigations (see Table 4 for infectious disease markers)
Haematology	Full blood count; coagulation screen (including PT, APTT and fibrinogen); ESR; blood film; haemoglobin electrophoresis or high-pressure liquid chromatography
Biochemistry	Urea and electrolytes; liver function tests; LDH; ferritin; random glucose; beta-HCG (for females of child-bearing age)
Optional tests	Chest x-ray; electrocardiogram; urinalysis

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title	Table 4 - Recommended minimum standard of donor infectious disease marker testing

Recommended minimum testing for infectious disease markers

Stage	Infectious disease	Recommended validated assay
Recruitment	Nil	Nil
CT-stage	HIV	HIV antibody
	Hepatitis B	Hepatitis B surface antigen
	Hepatitis C	Hepatitis C antibody
Work-up	HIV	HIV 1,2 antibody
		p24 antigen
		HIV RNA
	Hepatitis B	Hepatitis B surface antigen
		Hepatitis B surface antibody
		Hepatitis B core antibody
		Hepatitis B DNA
	Hepatitis C	Hepatitis C antibody
		Hepatitis C RNA
	HTLV I+II	HTLV I+II antibody
	Syphilis	Validated serological testing algorithm

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title	Table 5 - Recommended schedule for repeating donor assessments in the event of a delay to collection - updated!

Repeating assessments required in the event of a delay to collection

Time from work-up medical assessment to collection	Repeat assessments required
<=30 days	None
>30 days, <90 days	Required: Infectious disease markers Risk assessment¹ for transmittable disease Full donor history if subsequent donation Optional²: Full donor history if first donation Physical examination All laboratory testing excluding haemoglobinopathy screening Additional testing (per discretion of physician in charge)
>=90 days, <6months	Required: Infectious disease markers Risk assessment for transmittable disease Full donor history if subsequent donation All laboratory testing excluding haemoglobinopathy screening Optional: Full donor history if first donation Physical examination Additional testing (per discretion of physician in charge)
>=6 months	Required: Infectious disease markers Full donor history including risk assessment for transmittable disease Physical examination All laboratory testing excluding haemoglobinopathy screening Optional (per discretion of physician in charge): Additional testing that was performed at the original work-up, such as chest X-ray, ECG or urinalysis.

¹Risk assessment does not necessarily mean a full risk questionnaire, but means a risk assessment based on local policies, endemic risks and previous individual risk assessments and/or infectious disease marker results. Especially in young donors, a travel history seems appropriate.

²Optional: per discretion of the donor physician in charge or as required by standards or (national) legislation.

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title	Table 6 - Recommended intervals between HPC donations and other blood(product) donations

Recommended intervals between HPC donations and other blood(product) donations

WB to HPC interval	If a donor reports donating WB within the last 3 months, report to collection centre physician
Plasmapheresis or plateletphereris to HPC interval	2 weeks
HPC(A) to WB interval	Advise donor to wait 3 months (i.e. equivalent to one WB => WB interval)
HPC(M) to WB interval	Advise donor to wait 6 months (i.e. equivalent to one WB => WB interval)
HPC(A) to plasmapheresis interval	Advise donor to wait 2 weeks (i.e. a typical plasmapheresis => plasmapheresis interval)
HPC(M) to plasmapheresis interval	Advise donor to wait 4 weeks (i.e. a typical WB => plasmapheresis interval)
HPC(A) to plateletpheresis interval	Advise donor to wait 2 weeks (i.e. a typical plateletpheresis => plateletpheresis interval)
HPC(M) to plateletpheresis interval	Advise donor to wait 4 weeks (i.e. a typical WB => plateletpheresis interval)