Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on November 21, 2024 by The Health Master
FAQs – on Blood Bank / Centre (Part-1)
Q1. Whether Blood and its components are Drugs?
Ans: Yes, as per section 3 (b) of the Drugs and Cosmetics Act, 1940 Blood and its components are Drugs.
Q2. When national Blood policy on Blood safety formed?
Ans: Yes, it is formed in the year 2002.
Q3. How much area is required to start blood centre?
Ans: To start Blood Centre, the area required is:
For whole human blood IP 100 sq.mt.
For components 50 sq.mt. and
For Aphaeresis 10 sq. mt.
Q4. Who is Licensing Authority for issuing blood Centre license?
Ans: It is under dual licensing system i.e. CLAA and SLA
Q5. How many rooms are required for blood Centre?
Ans:
1. Registration
2. Medical Examination room *
3. Blood collection room *
4. Serology lab room *
5. TTI lab room *
6. Sterilization and washing room
7. Refreshment room *
8. Store cum records room
9. Component room (20 to 25 0 C) *
10. Counseling area with adequate privacy
11. Identified Quality Control area with component preparation
Q6. Which rooms are required air conditioners?
Ans: Room no. 2, 3, 4, 5, 7 & 9 required air conditioners.
Q7. How much is the fee for grant / renewal of blood Centre license?
Ans: Rs. 7500/-
Q8. How much is the fee for additional item (component)?
Ans: Rs. 300/- per component.
Q9. What the latest standards of blood and its components?
Ans: Latest Pharmacopoeial status of Blood and its components:
1. Whole Human Blood I.P.
2. Concentrated Human Red Blood Corpuscles IP (Packed Red Blood Cells).
3. Saline washed Red Cells.
4. Leucodepleted Red cells.
5. Irradiated Red cells
6. Frozen Packed Red Blood Cells.
7. Packed red cell aliquout.
8. Platelet Concentrate I.P.
9. Platelet Rich Plasma.
10. Pooled Platelets.
11. Leucodepleted Platelet.
12. Washed Platelets.
13. Irradiated Platelets.
14. Fresh Frozen Plasma
15. Cryoprecipitated AHF IP
16. Pooled Cryoprecipitate.
17. Plasmapheresis (By Cell Separator leading to single donor plasma).
18. Plateletpheresis ( By Cell Separator leading to single donor platelet).
19. Granulocyte concentrate.
20. Leucapheresis.
21. Erythroytaphresis.
22. Haematopoietic stem cells (Peripheral Blood Stem Cells).
23. Therapeutic Plasmapheresis and Cytapheresis.
24. Cytapheresis.
25. Cryo Poor Plasma
26. Platelet Additive Solution
Q10. Whether blood centre can be centrally air conditioned?
Ans: It can be centrally air conditioned, but TTI lab cannot be connected with the central A/C duct to avoid cross contamination.
Also read: FAQs on Medical Devices Rules, 2017
Q11. What should be the condition of walls and floors of the rooms where blood is collected or component area?
Ans: Walls & floor shall be smooth and washable
Q12. Whether separate footwear / dedicated footwear required in blood centre working?
Ans: Yes, foot covers is required in Blood donor room for Blood donors.
Q13. What is the qualification of Medical Officer (MO) / Blood Transfusion Officer (BTO) working in blood centre?
Ans:
(a) Degree in Medicine M.B.B.S. having experience of working in Blood Centre, not
less than one year during regular service and also has adequate knowledge and experience in blood group serology, blood group methodology and medical
principles involved in the procurement of blood or preparation of its components or
both; or
(b) Degree in Medicine M.B.B.S. with Diploma in Clinical Pathology or Diploma in
Pathology and Bacteriology with six months experience in a licensed Blood Centre;
or
(c) Degree in Medicine M.B.B.S. with Diploma in Transfusion Medicine or Diploma in
Immunohematology or Blood Transfusion with three months experience in a
licensed Blood Centre; or
(d) Doctor of Medicine Pathology or Diplomate of National Board Pathology with three
months experience in a licensed Blood Centre; or
(e) Postgraduate degree in Transfusion Medicine – Doctor of Medicine Transfusion
Medicine or Diplomate of National Board Transfusion Medicine, Doctor of
Medicine Immunohematology and Blood Transfusion, the degree or diploma being from a University recognized by the Central Government or State Government.
Explanation.― For the purposes of this condition, the experience in Blood Centre shall
not apply in the case of persons who are approved by the Licensing Authority or Central
Licence Approving Authority or both prior to the commencement of the Drugs and
Cosmetics (Second Amendment) Rules, 1999.
Q14. What is the qualification of Blood centre Technician in blood centre?
Ans:
(i) Diploma in Medical Laboratory Technology (DMLT) or Transfusion
Medicine or Blood Bank Technology after 10+2 with one year
experience in the testing of blood and/or its components in licensed
Blood Centre; or
(ii) Degree in Medical Laboratory Technology (M.L.T.) or Blood Bank
Technology with six month‘s experience in the testing of blood
and/or its components in licensed Blood Centre; or
(iii) B.Sc. in Hematology and Transfusion Medicine with six month‘s
experience in the testing of blood and/or its components in licensed
Blood Centre; or
(iv) M.Sc. in Transfusion Medicine with six month‘s experience in the
testing of blood and/or its components in licensed Blood Centre; or
(v) Post Graduate Diploma in Medical Laboratory Technology
(PGDMLT) / Post Graduate Diploma in Medical Laboratory Science
(PGDMLS) with six month‘s experience in the testing of blood and/or
its components in licensed Blood Centre.
(Note: Diploma and degree should be from recognized university i.e. Central Govt. or State Govt.)
Q15. What is the qualification of Technical Supervisor in blood centre?
Ans:
(i) Diploma in Medical Laboratory Technology or Transfusion Medicine
or Blood Bank Technology after 10+2 with one year experience in the
testing of blood or its components or both in licensed Blood Centre;
or
(ii) Degree in Medical Laboratory Technology or Blood Bank
Technology with six month‘s experience in the testing of blood or its
components or both in licensed Blood Centre; or
(iii) B.Sc. in Hematology and Transfusion Medicine with six month‘s
experience in the testing of blood or its components or both in
licensed Blood Centre; or
(iv) M.Sc. in Transfusion Medicine with six month‘s experience in the
testing of blood or its components or both in licensed Blood Centre;
or
(v) Post Graduate Diploma in Medical Laboratory Technology or Post
Graduate Diploma in Medical Laboratory Science with six month‘s
experience in the testing of blood or its components or both in
licensed Blood Centre; or
(vi) Post Graduate Diploma in Transfusion Technology (PGDTT)
approved by the Central Government or State Government with
experience of 6 months in testing of blood or its components or both
in licensed blood centre.
(Note: Diploma and degree should be from recognized university i.e. Central Govt. or State Govt.)
Q16. What are the main criteria for blood donation?
Ans:
1. Donor’s age is 18 to 65 years
2. Weight should not be less than 45 kg.
3. Haemoglobin should not be less than 12.5 gms.
(Note: There is a provision of temporary debarring / suspension of Blood donor who is suffering from ailments given in the Drug Act.)
Q17. Can a person donate blood, who has once infected with hepatitis infection?
Ans: Never.
Q18. Is empty Blood bag a Drug?
Ans: Blood bag containing CPDA solution is medical device, falls under the category of Class C of MDR 2017.
Q19. What are the mandatory tests to be carried by blood centre on whole human blood?
Ans:
1. HIV
2. Hepatitis B
3. Hepatitis C
4. VDRL
5. Malaria parasite
Q20. When ELIZA test or rapid test for hepatitis and HIV was introduced in India?
Ans: These tests are introduced on 21.12.2005 (as per GSR 733(E) dated 21.12.2005).
To know about requirements for blood donation camp, click here.
To know about operation of blood storage centre, click here.
FAQs – on Blood Bank / Centre (Part-2)
FAQs – on Blood Bank / Centre (Part-3)
FAQs on Legal Metrology & Blood Bags
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