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WMDA Donor Medical Suitability Recommendations

Disclaimer

These guidelines exist as an aid to unrelated adult haematopoietic stem cell donor registries in assessing the medical suitability of their donors. However, donor registries are reminded that these guidelines are not intended to supersede local laws or requirements of national legislative bodies.Ā 

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 donor medical suitability working group of the WMDA. 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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titleAbout 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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titleHow 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 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 best placed to make an informed risk-benefit judgement on whether to proceed with that particular donor.
  • There are obvious exceptions to this, however, in particular the carriage of transmissible agents which may have more deleterious effects in the recipient. These include infectious agents such as HIV, viral hepatitis and HTLV, prion-related diseases such as Creutzfeld-
Jacob
  • Jakob Disease, and carriage of
autoreactive
  • auto-reactive lymphocytes causing multi-system or severe single-organ autoimmune diseases, such as systemic lupus erythematosus, multiple sclerosis or inflammatory bowel disease.
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titleProcedure for
Procedure for
creating and reviewing the donor medical suitability guidelines

To create and support this resource, the WMDA has established the donor medical suitability

working group

To 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.

committee. Members of the committee represent all major regions in the world, and are themselves overseen by numerous competent authorities within their country of practice. Committee members are actively involved in donor centre and/or registry operations with experience in matters concerning unrelated donor medical suitability.

You can find the members here: https://share.wmda.info/x/So1JAQ.

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Submitting a request for review
The

WMDA welcomes requests for review of individual medical conditions from all those with responsibility for HSC donors, related or unrelated. This may be a medical condition not covered by the current guidance, or a request for clarification or review of current guidance.

Requests for new guidance, and feedback on existing guidance, are submitted to the

committee chair/designate and reviewed by committee members

donor medical suitability committee. Comments and justifications for the committee decision are documented, including justification for the decision. Regardless of the outcome, a formal response to the query is provided to the author of each submission in order to inform the registry/donor centre of the outcome of the discussion. Recommendations that are approved are posted to this website. Any controversies pertaining to the recommendations are added to the discussion section on the relevant page.

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.

You can click on the button on the right top corner of the page.


Add your question or recommendation at the question sectionĀ or send an email toĀ mail@wmda.info.Ā 

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titleWMDA Recommendations for assessing donor medical suitability
Expand
titleTable
1Ā 
1Ā - Recommended
minimum
medical and lifestyle information
obtained
at
recruitment
enrolment - updated!

Medical

Table 2Ā - Recommended minimum medical

and lifestyle information at enrolment - updated!

ImportanceMedical historyExamples 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 ā€“ latex; anaesthetic

Expand
titleTable 2Ā - 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 historyExamples of relevant conditions or questions
Cancer
Autoimmune diseaseAnkylosing spondylitis; Crohnā€™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 individualHIV, Hepatitis B, Hepatitis C, HTLV, syphilis
Infectious diseases, othersCJD (including familial and exposure risk, e.g. neurosurgery, use of pituitary hormone), Chagas disease, tuberculosis, malaria
Back problemsAny acute or chronic back complaint, including cause, investigations, duration, medication and impact on activities of daily living
HypertensionMost recent blood pressure readings; medications; degree of control
Cardiac diseaseCoronary artery disease; evidence of valve disease, e.g. murmur; arrhythmia
AsthmaDegree of control; medications; use of oral steroids; hospital admissions; intensive care admissions/ventilation
EpilepsyMedications; date of last seizure
PregnancyNumber of pregnancies, including miscarriage; current/recent pregnancies; breastfeeding.
Blood transfusionReceipt of a blood transfusion. Ask year and place of transfusion.
Any other medical historyThe potential donor should be asked if they have any other past or current medical problems
Height and weight
High risk sexual behaviourAs defined by the registryā€™s national competent authority
Non-prescription parenteral drug use
Alcohol consumption
Tattoo, acupuncture or body piercingWhen and where. Establish if at an establishment registered according to national regulations
Current medications
Allergies
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titleTable 3Ā - Recommended medical assessment at work-up - updated!

Medical assessment at work-up - updated!

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 Chagasā€™ 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

Expand
titleTable 4Ā - Recommended minimum standard of donor infectious disease marker testing

Recommended minimum testing for infectious disease markers

StageInfectious diseaseRecommended validated assay
RecruitmentNilNil
CT-stageHIVHIV antibody

Hepatitis BHepatitis B surface antigen

Hepatitis CHepatitis C antibody
Work-upHIVHIV 1,2 antibody


p24 antigen


HIV RNA

Hepatitis BHepatitis B surface antigen


Hepatitis B surface antibody


Hepatitis B core antibody


Hepatitis B DNA

Hepatitis CHepatitis C antibody


Hepatitis C RNA

HTLV I+IIHTLV I+II antibody

SyphilisValidated serological testing algorithm
Expand
titleTable 5Ā - Recommended schedule of for repeating donor assessments in the event of a delay to collection - updated!

Repeating assessments required in the event of a delay to collection - updated!

Time from work-up medical assessment to collection

Repeat assessments required

<=30 daysNone
>30 days, <90 days

Required:

  • Infectious disease markers
  • Risk assessment1Ā 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.

Expand
titleTable 6 - Recommended intervals between HPC donations and other blood(product) donations

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

A WMDA working group is currently reviewing an article that was written on the subject of subsequent donations. Read more on the project and find the article on this page in Share.

WB to HPC intervalIf a donor reports donating WB within the last 3 months, report to collection centre physician
Plasmapheresis or plateletphereris to HPC interval2 weeks
HPC(A) to WB intervalAdvise donor to wait 3 months (i.e. equivalent to one WB => WB interval)
HPC(M) to WB intervalAdvise donor to wait 6 months (i.e. equivalent to one WB => WB interval)
HPC(A) to plasmapheresis intervalAdvise donor to wait 2 weeks (i.e. a typical plasmapheresis => plasmapheresis interval)
HPC(M) to plasmapheresis intervalAdvise 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 intervalAdvise donor to wait 4 weeks (i.e. a typical WB => plateletpheresis interval)
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obtained at confirmatory/verification typing stage

Table 3Ā - Recommended minimum medical assessment at work-up

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

Table 5Ā - Recommended schedule of repeating donor assessments in the event of a delay to collection
Alphabetical index of individual medical guidelines

A

Acupuncture, seeĀ Tattoo, body piercing and acupuncture

Alcohol intake

Alcoholism, seeĀ Alcohol intake

Allergy

Alopecia areata, seeĀ Single organ autoimmune disease

Anaemia

Anaphylaxis, seeĀ Allergy

Angina, seeĀ Coronary artery disease

Ankylosing spondylitis, seeĀ Back complaints

Antiphospholipid syndrome, seeĀ Thrombosis and Thrombophilia

Antithrombin III (ATIII) deficiency, seeĀ Thrombosis and Thrombophilia

Aortic regurgitation, seeĀ Valvular heart disease

Aortic stenosis, seeĀ Valvular heart disease

Arrhythmia

Arterial thrombosis, seeĀ Thrombosis and Thrombophilia

Asthma

Atrial fibrillation/flutter, seeĀ Arrhythmia

Atopy, seeĀ Allergy

B

Babesiosis

Back complaints

Back, fracture, seeĀ Back complaints

Back, surgery, seeĀ Back complaints

Basal cell carcinoma, seeĀ Malignancy

Benign atrial/ventricular ectopics, seeĀ Arrhythmia

Benign tumors

Bicuspid aortic valve, seeĀ Valvular heart disease

Bipolar affective disorder

Bleeding disorders

Blood pressure, seeĀ Hypertension

BMI, seeĀ Weight

Body piercing, seeĀ Tattoo, body piercing and acupuncture

Breastfeeding, see Pregnancy and breastfeeding

Bronchial asthma,

seeĀ 

see Asthma

Brugada syndrome, seeĀ Arrhythmia

Budd-Chiari syndrome, seeĀ Thrombosis and Thrombophilia

C

Cancer, seeĀ Malignancy

Cerebral venous sinus thrombosis, seeĀ Thrombosis and Thrombophilia

Cerebrovascular disease

Cevical carcinoma in-situ, seeĀ Malignancy

Chagas disease

Choreoretinitis, seeĀ Inflammatory eye disease

Chronic fatigue syndrome, seeĀ Myalgic encephalomyelitis

Chronic obstructive pulmonary disease

CMV, seeĀ Cytomegalovirus

Coeliac/celiac disease, seeĀ Single organ autoimmune disease

Complete heart block, seeĀ Arrhythmia

COAD/COPD, seeĀ Chronic obstructive pulmonary disease

Conjunctivitis, seeĀ Inflammatory eye disease

Cornea transplant, seeĀ Prion-associated disease

Coronary artery disease

Coronavirus, see COVID-19

Coumarin therapy, seeĀ Bleeding disorders

COVID-19

Creutzfeld-Jacob disease (CJD, vCJD), seeĀ Prion-associated disease

Crohn's disease, seeĀ Severe or systemic autoimmune disease

Cytomegalovirus

D

Deep vein thrombosis (DVT), seeĀ Thrombosis and Thrombophilia

Dengue Fever

Depression

Diabetes mellitus

E

Ebola, seeĀ Viral haemorrhagic fever

Ebstein anomaly, seeĀ Valvular heart disease

EBV, seeĀ Epstein Barr Virus

Eczema

Endometriosis

Emphysema, seeĀ Chronic obstructive pulmonary disease

Endoscopy, seeĀ Surgery

Epilepsy

Episcleritis, seeĀ Inflammatory eye disease

Epstein Barr Virus

F

Factor II (prothrombin) mutation, seeĀ Thrombosis and Thrombophilia

Factor V Leiden, seeĀ Thrombosis and Thrombophilia

Fibromyalgia

First degree heart block, seeĀ Arrhythmia

G

Glaucoma

Glomerulonephritis, seeĀ Renal disease

Goodpasture syndrome, seeĀ Severe or systemic autoimmune disease

Graves disease, seeĀ Single organ autoimmune disease

Guillain-Barre syndrome, seeĀ Severe or systemic autoimmune disease

Gout

H

Haemoglobin disorder

Haemophilia (any type), seeĀ Bleeding disorders

Hashimoto thyroiditis, seeĀ Single organ autoimmune disease

Hayfever, seeĀ Allergy

HbC, HbD, HbE, HbO, seeĀ Haemoglobin disorder

Heart attack, seeĀ Coronary artery disease

Heart block, seeĀ Arrhythmia

Heart murmur, seeĀ Valvular heart disease

Hemochromatosis

Heparin therapy, seeĀ Bleeding disorders

Hepatitis B

Hepatitis C

Hepatitis E

Hereditary elliptocytosis

Hereditary haemorrhagic telangiectasia,

seeĀ 

see Bleeding disorders

Herniated intervertebral disc, seeĀ Back complaints

Herpes simplex virus

High affinity haemoglobin, seeĀ Haemoglobin disorder

High blood pressure, seeĀ Hypertension

High risk sexual behaviour

HIV

Hormone replacement therapy, seeĀ Prion-associated disease

HSV, seeĀ Herpes Simplex Virus

HTLV infection

Hypertension

Hyperthyroidism, seeĀ Single organ autoimmune disease

Hypothyroidism, seeĀ Single organ autoimmune disease

I

IgA nephropathy, seeĀ Renal disease

Immune thrombocytopenia, seeĀ Bleeding disorders

Implantable cardiac defibrillator (ICD), seeĀ Arrhythmia

Inflammatory bowel disease, seeĀ Severe or systemic autoimmune disease

Inflammatory eye disease

Innocent murmur, seeĀ Valvular heart disease

Injection of non-prescription drugs

Innoculation injury

Iridocyclitis, seeĀ Inflammatory eye disease

Iritis, seeĀ Inflammatory eye disease

Ischaemic heart disease (IHD), seeĀ Coronary artery disease

J

Jugular vein thrombosis, seeĀ Thrombosis and Thrombophilia

K

Kidney stones, seeĀ Renal disease

L

Latex allergy, seeĀ Allergy

Left bundle branch block, seeĀ Arrhythmia

Long-QT syndrome, seeĀ Arrhythmia

Lown-Ganong-Levine syndrome, seeĀ Arrhythmia

M

Malaria

Malignancy

Manic depressive disorder, seeĀ Bipolar affective disorder

Marburg, seeĀ Viral haemorrhagic fever

Mitral regurgitation, seeĀ Valvular heart disease

Mitral stenosis, seeĀ Valvular heart disease

Mitral valve prolapse, seeĀ Valvular heart disease

Monoclonal gammopathy of undetermined significance

Multiple sclerosis, seeĀ Severe or systemic autoimmune disease

Murmur, seeĀ Valvular heart disease

Myalgic encephalomyelitisĀ (ME)

Myocardial infarction (MI), seeĀ Coronary artery disease

N

Needlestick injury, seeĀ Innoculation injury

Nephrectomy, seeĀ Renal disease

Nephritis, seeĀ Renal disease

Nephrolithiasis, seeĀ Renal disease

Nephrotic syndrome, seeĀ Renal disease

O

Obstructive sleep apnoea

Osler-Weber-Rendu syndrome, seeĀ Bleeding disorders

Oral anticoagulant therapy, seeĀ Bleeding disorders

Osteoporosis

Overweight, seeĀ Weight

P

Pacemaker, seeĀ Arrhythmia

Paget-Schroetter syndrome, seeĀ Thrombosis and Thrombophilia

Pernicious anaemia, seeĀ Single organ autoimmune disease

Paroxysmal nocturnal haemoglobinuria (PNH), seeĀ Thrombosis and Thrombophilia

Pneumothorax

Portal vein thrombosis, seeĀ Thrombosis and Thrombophilia

Pregnancy and breastfeeding

Prion-associated disease

Prolapsed intervertebral disc, seeĀ Back complaints

Protein C deficiency, seeĀ Thrombosis and Thrombophilia

Protein S deficiency, seeĀ Thrombosis and Thrombophilia

Prostitution, seeĀ High risk sexual behaviour

Psoriasis, seeĀ Single organ autoimmune disease

Pulmonary embolus/embolism (PE), seeĀ Thrombosis and Thrombophilia

Pulmonary regurgitation, seeĀ Valvular heart disease

Pulmonary stenosis, seeĀ Valvular heart disease

Q

R

Renal colic, seeĀ Renal disease

Renal disease

Renal vein thrombosis, seeĀ Thrombosis and Thrombophilia

Retinitis pigmentosa

Rheumatoid arthritis, seeĀ Severe or systemic autoimmune disease

Right bundle branch block, seeĀ Arrhythmia

S

Sarcoidosis, seeĀ Severe or systemic autoimmune disease

Sciatica, seeĀ Back complaints

Scleritis, seeĀ Inflammatory eye disease

Scleroderma, seeĀ Severe or systemic autoimmune disease

Second degree heart block, seeĀ Arrhythmia

Seizure, seeĀ Epilepsy

Sex worker, seeĀ High risk sexual behaviour

Severe or systemic autoimmune disease

Sickle cell disease, seeĀ Haemoglobin disorder

Sickle cell trait, seeĀ Haemoglobin disorder

Single organ autoimmune disease

Sinus bradycardia, seeĀ Arrhythmia

Sinus tachycardia, seeĀ Arrhythmia

Spinal stenosis, seeĀ Back complaints

Spondylitis, seeĀ Back complaints

Spondylolisthesis, seeĀ Back complaints

Stroke, seeĀ Cerebrovascular disease

Supraventricular tachycardia, seeĀ Arrhythmia

Surgery

SVT, seeĀ Arrhythmia

Syphilis

Systemic lupus erythematosus (SLE), seeĀ Severe or systemic autoimmune disease

T

Tattoo, body piercing and acupuncture

Thalassaemia, seeĀ Haemoglobin disorder

Thrombosis and Thrombophilia

Thrombotic thrombocytopenic purpura (TTP), seeĀ Severe or systemic autoimmune diseaseĀ orĀ Bleeding disorders

Thyroid disease, seeĀ Single organ autoimmune disease

Toxoplasmosis

Transfusion

Transient ischaemic attack (TIA), seeĀ Cerebrovascular disease

Tuberculosis

U

Ulcerative colitis, seeĀ Severe or systemic autoimmune disease

Underweight, seeĀ Weight

V

Valvular heart disease

Ventricular tachycardia/fibrillation, seeĀ Arrhythmia

Viral haemorrhagic fever

Vitiligo, seeĀ Single organ autoimmune disease

Von Willebrand disease (vWD), seeĀ Bleeding disorders

Vitamin K deficiency, seeĀ Bleeding disorders

W

Warfarin therapy, seeĀ Bleeding disorders

Wegener granulomatosis, seeĀ Severe or systemic autoimmune disease

Weight

Wenckebach (Mobitz I) heart block, seeĀ Arrhythmia

West Nile Virus

Whiplash, seeĀ Back complaints

X

Y

Z