Blood Security -Dr. Rajesh Gopal 1

2

3

4

5

6

Blood Security – Equitable and timely access to  Sufficient (adequate collection),  Safe (free from transmissible infections) and  Suitable (grouped and cross matched) blood in all parts of a state/nation at the time of need. 7

 About 38% of maternal deaths occur due to haemorrhage (Sample Registration System-2005)  Systematic review (WHO) of 34 datasets- percentage of maternal deaths from haemorrhage was higher than previously estimated by WHO (Khan KS et al, WHO analysis of cause of death: a systematic review, Lancet 2006;367: ). 8

 4 th January, 1996  (Common Cause Judgment- -a blue print for blood safety !)  20 th December, 2001  (blood storage centres linked to mother blood banks through DCR, a roadmap to blood security ?) 9

 A management consultancy firm M/s. A.F. Ferguson & Co. to study blood banking system in the country (1990) to:  (i) assess the blood banks ;  (ii) recommend policy and procedure changes and  (iii) prepare a scheme for modernisation : 10

 M/s. A.F. Ferguson & Co ( July, 1990), high-lighted severe deficiencies in the facilities of testing of blood in banks, licensing of blood banks, issues of professional donors and storage of blood like:-  About 60% of blood banks WITHOUT license  No check on professional blood selling 11

Action during pendency/hearing of writ petition –PIL(Article 32 of Constitution)  Affidavit by Addl. Director, NACO, along with the scheme, stated that the Central Council of Health, (the State Health ministers are members) being highest Forum for Policy frame work provided guidelines in respect of Blood Bank and Transfusion Service and the Joint Conference made recommendations.  Joint Conference recommended that urgent steps should be taken by the State/Union Territories Governments and the Central Government. - 12

 1. adequate blood banking services at State/District level with trained/qualified human resources.  2. to educate and motivate people about blood donation on a voluntary basis.  3. to provide adequate encouragement to voluntary donors.  4. to enforce quality control of blood in all its facets of collection, distribution and storage. 13

 I. Long term objectives:  (a) Make available high quality blood and blood components in adequate quantity to all users.  (b) Ensure wide usage of blood components.  (c) Expand voluntary and replacement donor base, so as to phase out professional blood donors. 14

 II. Medium term objectives:  (a) Facilities for blood collection, storage and testing in all govt. blood banks.  (b) Trained human resources in all govt. blood banks.  (c) Awareness of clinicians on the advantages of blood components.  (d) Effective geographical coverage with different requirement in different areas.  (e) Public awareness about the risks in using blood from professional donors and the harmlessness of blood donation. 15

 Committee constituted by the court ( )  1. Additional Secretary, Ministry of Health holding the charge of Project Director, National AIDS Control Organisation as Chairman.  2. Drugs Controller of India.  3. Mr. H.D. Shourie. 16

 Indian Red Cross Society (I.R.C.S.)recognised as nodal agency in the field of blood banking and blood transfusion technology in the country  The I.R.C.S. constituted a committee of experts to examine the matter.  The committee of experts submitted its detailed report on April 15,

 Recommendations of Experts’ committee  1. voluntary blood donation movement to augment supplies of safe quality blood  2. Exercising economy by processing whole blood for blood components.  3. To minimize the danger of transmissible diseases like AIDS, Hepatitis etc.  4. Standardize procedures(SOPs) for quality control, and good manufacturing practices. 18

 NBTC and SBTCs to be formed with launching of effective motivation campaigns  Professional ‘donors’ to be completely eliminated within two years.  Plan of Action prepared. Plan of Action prepared 19

 Urban-centric blood transfusion service with limited access to blood in sub-urban/rural areas  Need of blood storage centres in public and non-governmental sectors. Is a licence required for functioning of a blood storage centre ? 20

 need to utilize the available legal and infrastructural provisions.  cost-effective strategy is to establish a blood storage centre at NGO sector and each CHC of tribal /remote areas  Establishment of a blood storage centre does not require a license or additional human resources 21

 Exemption : - Ministry of Health & Family Welfare (Dept. of Health) vide Notification No.GSR 909(E) dated 20 th December,2001 under Schedule K of Drugs & Cosmetics Rules,1945, under serial no.5B.  Aim of the notification: - To make abundant availability of blood to the blood storage centre run by FRU, Community Health Centre, PHC or any hospital without taking license. 22

State-wise blood requirements and blood collection : (Total blood collected in in Gujarat = 7,07,000 units) Pop – 5.96 cr. 24

Blood Storage Centres Sr. No. District Functional Centre at FRU Functional Centre at non-govt. sector FDCA Approval pending in CHC(NGO) centres To be functional in short time Total Ahmedabad Anand Amreli Banaskantha Bharuch Bhavnagar 222 (1)1 7 7Dahod Dang Gandhinagar Jamnagar Junagadh Kheda Kutch 211 (1)2 6 14Mehsana Narmada Navsari Porbandar Panchmahal Patan Rajkot Sabarkantha Surat 163(1) Surendranagar Vadodara Valsad Total (3)