STANDARD OPERATING PROCEDURE (SOP): CRITERIA FOR BLOOD DONOR SELECTION

                                                     HOSPITAL NAME

                                                         BLOOD CENTRE

Number	Effective Date	Pages			Author	Authorised by
Version	Review Period	No. of Copies			Reviewed by	Dat

1. SCOPE & APPLICATION

This SOP describes the criteria for a donor to be accepted for blood donation, for ensuring safety of donor as well as recipient. The purpose of donor selection is to identify any factors that might make an individual unsuitable as a donor, either temporarily or permanently.

2. RESPONSIBILITY

The Medical Officer is responsible for determining the suitability of donor for blood donation. He/She should confirm that the criteria are fulfilled after evaluation of health history questionnaire and medical examination including the results of pre donation screening tests.

3. REFERENCES

The Gazette of India – Published on March 11^th 2020

4. MATERIAL REQUIRED

• Donor Questionnaire

• Donor Card

5. PROCEDURE

CRITERIA FOR SELECTION OF BLOOD DONORS

A. Accept only voluntary/replacement non-remunerated blood donors if following criteria are fulfilled.

The interval between blood donations should be no less than three months (90 days) for Males and no less than four months (120 days) for Females . The donor shall be in good health, mentally alert and physically fit and shall not be a jail inmate or a person having multiple sex partners or a drug-addict. The donors shall fulfill the following requirements, namely:-

1. The minimum age of the donor shall be 18 years and maximum age shall be 65 years for repeat donor and 60 years for first time donors.

• The donor shall not be less than 45 kilograms

• Temperature and pulse of the donor shall be normal

• The systolic blood pressure must be within the range of 100-140 mm of Hg and diastolic blood pressure 60-90 mm of Hg are with or without medications.

• Haemoglobin shall not be less than 12.5 g/dL

• The donor shall be free from acute respiratory diseases

• The donor shall be free from any skin disease at the site of phlebotomy

• The donor shall be free from any disease transmissible by blood transfusion, in so far as can be determined by history and examination indicated above

• The arms and forearms of the donor shall be fee from skin punctures or scars indicative of professional blood donors or addiction of self-injected narcotics

• Defer the donor for the period mentioned as indicated in the following table:

CONDITIONS	PERIOD OF DEFERMENT
Abortion	6 months
History of blood transfusion	12 months
Major Surgery	12 months after recovery
Minor Surgery	6 months after recovery
Typhoid fever	12 months after recovery
History of Malaria duly treated	3 months following full recovery
Tattoo	12 months
Breast feeding	Defer for a total period of Lactation
Immunization(Cholera, Typhoid,Influeza Diphtheria,Tetanus,Plague, Gammaglobulin)	14 days
Anti-Rabies vaccination	1 year after vaccination
Hepatitis in family or close contact	12 months
Hepatitis Immune globulin	12 months

• Defer the donors permanently if suffering from any of the following diseases:

1. Asthmatic attack or asthmatics on steroid
   1. Open heart surgery including By-pass surgery
   1. Cancer surgery

• Heart disease- Has any active symptom (Chest Pain, Shortness of breath, swelling of feet)

                          -Myocardial infarction (Heart Attack)

                             -Cardiac medication (digitalis, nitro-glycerine)

                            -Hypertensive heart disease

                          -Coronary artery disease

                         – Angina pectoris

                         -Rheumatic heart disease with residual damage

5. Psychiatric disease- Convulsions and Epilepsy

                                   -Schizophrenia

6. Diabetes- If the person requires insulin and/or complications of Diabetes with multi organ involvement

7. Thyroid disorders- Permanently defer if: 1) Thyrotoxicosis due to Graves‘ Disease 2) Hyper/Hypo Thyroid 3) History of malignant thyroid tumours

8. Other endocrine disorders

9. Hepatitis – Known Hepatitis B, C – Permanently defer

                     Unknown Hepatitis – Permanently defer

1. Chronic Liver disease/Liver Failure-  Permanently defer

1. At risk for HIV infection (Transgender, Men who have Sex with Men, Female Sex Workers, Injecting drug users, persons with multiple sex partners)

1. Known HIV positive person or spouse/ partner of PLHA (person living with HIV AIDS)

1. Persons having symptoms suggestive of AIDS

1. Syphilis (Genital sore, or generalized skin rashes)

1. Gonorrhoea

1. Leishmaniasis

1. Leprosy

1. Chronic infection of kidney/ kidney disease/ renal failure

1. Other diseases:-
2. Autoimmune disorders like Systemic lupus erythematosis, scleroderma, dermatomyositis, ankylosing spondylitis or severe rheumatoid arthritis Permanently defer

• Polycythaemia Vera
• Bleeding disorders and unexplained bleeding tendency.
• Malignancy
• Severe allergic disorders
• Haemoglobinopathies and red cell enzyme deficiencies with known    history of    haemolysis
  • Patients on Anti-arrhythmic, Anti-convulsions, Anticoagulant, Anti-thyroid drugs, Cytotoxic drugs, Cardiac Failure Drugs (Digitalis)
  • Recipients of organ, stem cell and tissue transplants
  • Donors who have had an unexplained delayed faint or delayed faint with injury or two consecutive faints following a blood donation.

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D. Private interview:

A detailed sexual history should be taken. Positive history should be recorded on confidential notebook.

E. Informed consent:

Provide information regarding:

1.     Need for blood

2.     Need for voluntary donation

3.     Regarding transfusion transmissible infections

4.      Need for questionnaire and honest answers

5.     Safety of blood donation

6.     How the donated blood is processed and used

7.    Tests carried out on donated blood

N.B. This gives the donor an opportunity to give his/her consent if they feel they are safe donors

• Request the donors to sign on the donor card indicating that he is donating voluntarily.

6. DOCUMENTATION

Enter all details in the donor questionnaire form/card and computer