Management in Indian blood banking system: True reality
N. Choudhury
Coordinator, Blood Safety; Gujarat State Council for Blood Transfusion, O-1 New MH Complex, Meghaninagar, Ahmedabad-380016, India
Correspondence to: Dr. N. Choudhury, Gujarat State Council for Blood Transfusion O-1 Block, New MH Complex, Meghaninagar, Ahmedabad-380016, INDIA. E-mail: nabajyoti_2000@yahoo.com
This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Blood transfusion service is a multibillion dollar profession/ business worldwide. Being Indian blood bank personnel, we may not like to call it as business. But in the real sense, it is a production industry with all the components of business built into it. Still, we will not like to call it a business because of the fear in our minds that our general population or blood donors will be annoyed with us and may not come to donate again. Many a times, we do not clarify to the donor at the time of donation that there is service charge for blood units. As a result, when the donor needs blood, it comes as a rude shock and he makes allegations of the ‘sale’ of blood. At that moment, the situation becomes embarrassing because we hesitate to accept that we follow a cost recovery system which is a part of the business.
Many of our friends may not like to call it a business. But do you ever think about the money involved in Indian blood transfusion services (BTS)? Let us calculate the figure. If we take the total blood collection in India as 7.5 million units yearly, 2% of blood is discarded (minimum) due to various reasons. If we deduct 2% of discarded blood, the total usable whole blood or red cells will be 6460,000 units in India. For blood components, let us take a conservative estimate that only 25% blood is separated into components. In that situation, we will have about 1,365,000 components for patients. Now to find out the total revenue generation across the country, let us take the service charge ceiling laid down by the National AIDS Control Organization (NACO). NACO has prescribed Rs. 850 per unit of whole blood or RBC and 6460,000 units will generate Rs.549,1000,000. On the other hand, components will attract revenue of Rs.68,2500,000 (@ Rs.500 per component on an average). Total revenue generated by whole blood/ red cells and components is Rs.617,3500,000 (or US$123270000 @ 1 USD= Rs.50). We have not calculated products prepared by aphaeresis technique because of non-availability of data. What does all this calculation mean to us? Indian BTS is a billion-dollar (Rs.617 crore) healthcare system and all of us are contributors to it.
Who are the managers of the Indian BTS, of this billion-dollar healthcare system? We have four types of blood banks/centers (from the administrative point of view) in India. They are managed by the public (government) sector, Indian Red Cross Society (IRCS), non-government organizations (NGOs, on not for profit basis) and corporate or commercial sectors. Let us discuss today how efficiently more than 2,460 blood banks in India are managed. Roughly, about 55% blood banks are from the government sector, 5% from the IRCS, about 20-25% are from the NGO sector and the rest are from corporate or profit-making sectors. If we look into the government sector, blood banks are run by blood bank in-charge or Blood Transfusion Officers (BTOs) who takes care of regular administration under the guidance (?) of the Medical Superintendents/ Director of that hospital. Many a times, the head of laboratory or pathology also takes charge of the blood bank. If it is a medical college (government or private), usually the head of the department of Pathology takes additional responsibilities of the blood bank. There are about 40 blood banks in the country which are separated from the Pathology department as independent Transfusion Medicine (Immunohematology & Blood Transfusion) department where trained technical personnel take care of regular administration. In case of IRCS blood banks, there is a committee which ‘officially’ manages administration through the blood bank in-charge or BTO. However, there is always some control from the local or state-level IRCS in the management. In the fourth sector, i.e. in the corporate sector, management is in better hands. Because they have to manage mainly with a small number of family replacement donations, professional hospital administrators or experienced businessmen manage blood banks behind the scene.
Our point of discussion in this issue is the management of blood banks in the NGO or in the private sector. Why do some NGOs want to start blood banks? There are various reasons. The most common reason is philanthropy. If an NGO wants to do philanthropic work in the medical field, usually they want to start a blood bank. Probably, blood bank runs on philanthropic voluntary blood donation and these NGOs want to supply blood at a cheaper price. They initially fail to realize that it is a branch of medicine which needs sophisticated equipment and highly skilled manpower. Many non-medical trustees or promoters do not realize that supply of safe blood is more important than giving free blood. When the nitty-gritty of the Drugs and Cosmetics Act comes, they fall back on a few known medical personnel for help. In some stages trustees come to realize the hard fact that blood banking is not as simple as managing their own business/ profession. Then, they want some qualified medical personnel who can run the blood bank. But the issue is that they do want to keep control on every aspect of the blood bank, from blood collection to issue. The medical officer in this type of situation becomes confused and feels obstructed in his work. Many blood bank medical officers across the country feel that they are not allowed to work with a free hand and frequently face obstruction even in technical work. Of course, this is being felt in the corporate sector also. This leads to frustration and points of differences between Trustees and the technical head of the blood bank. However, both sides try to compromise and the work goes on, may not be as smoothly as before. In other situations, when it goes beyond compromise, one has to leave. Who leaves? Trustees will not leave because it is their fiefdom till their last breath. Therefore, the medical officer goes for another option.
Why are NGO Trustees motivated to start blood banks, in many cases, when they are not from the medical profession? On the face of it, it is philanthropy. Many people feel that it is not the only reason. It is widely felt that they want to become a part of the ‘business’ in multi-billon rupees and to get a share in it. Becoming a Trustee in any blood bank gives you name and fame in the medical profession. ‘I can arrange blood during emergency from my blood bank’. This message gives personal mileage in the society. It helps the person to come into the limelight of the society. There are instances where Trustees even establish themselves in political and other social spheres through this route. Trustees keep on receiving important contacts from other parts of the society through blood donations. Blood camps organizers are usually leaders of the society. Many Trustees uses blood camp organizers for easy networking in personal interest. This networking usually extends to government circles through State Blood Councils and local politicians. Some people start blood banks keeping a larger business plan in mind. Blood banks attached to pathology laboratories want to keep doctors clientage with them. Blood need is one of them and they want to supply to their own group of doctors. Others want to create blood banks as a base to start commercial ventures like plasma fractionation, or as a source for hyperimmune serum and other blood components for business.
Every blood bank starts with a good intention with the highest morals in mind. However, personal interest intrudes into high morals and philanthropy which derail the initial vision and mission of the organization, many a times. There are lots of such interests. One of them is siphoning out money in the garb of NGO status. Other self-interests are to accommodate self or a coterie in the management, expansion of business by opening new blood bank branches, nepotism, sycophancy, putting one professional against another, personal rivalry among trustees etc. Once there is organizational degradation or deviation from the original vision/ mission, technical personnel in the blood banks are affected, especially the medical head. This person becomes sandwiched between moral/ technical standing of the organization and the narrow interest of the Trustees. They are victims of the whims of the Trustees. If you do not have a moral standing and simply follow Trustees’ instructions, you are welcome. In an opposite situation, you are a persona non grata. These types of Trustees look for somebody who complies with legal requirements but is at their mercy. I visited quite a few Trust-run blood banks all over India in my previous job. These are personal observations and inputs given by blood bank workers across the country. One observation was very interesting. Many Trust-run blood banks employ doctors with MBBS (basic medical graduation in the Indian system) degree who are more than 65 years of age. This type of decision takes care of three areas, legal requirement, personal part-time job of a retired person and Trustee can keep absolute control even in technical matters because the head of the technical team is at their mercy. This forces public to brand these type of Trustees as ‘Un-trustful Trustees’.
We have discussed the other side of the story with a few important Trustees all over India. A few of them complained that doctors do not listen to them; they want to run the blood bank (technical part) as they desire. One Trustee said that he had to terminate one doctor because he was mingling with some of his opponents. However, most of the Trustees agreed that lots needs to be done in the NGO sector to bring transparency. They all agreed that Trustees are not above the law and the law of the land should be followed to bring greater transparency in the NGO system. We agree with them that they are offering excellent service to the Indian BTS. If we go by statistics, voluntary blood donation is more in the NGO sector than all other sectors. NGO-run blood banks have a tremendous potential for positive contribution to the system. They have to come out of their selfish motive to earn from the multi billion rupees blood banking industry. One of the major complaints about Trusts is lack of transparency in the management of blood banks. The majority of the Trusts are constituted by main Trustees or promoters. These are usually constituted by family members or a captive population where Trustees can directly influence their decisions.
What is the solution to bring better administration to Trust run blood banks? Trustees should understand that quality of blood supplied to the society is more important than what discounts they are giving on each unit. Trustees are supplying a drug (blood unit) and quality cannot be compromised in the name of charity. Nobody is above the law and everybody has to follow the law of the land, whether it is Drugs and Cosmetics Act and various NACO directives including service charges of blood. It is high time to bring transparency in Trust run blood banks. Let various Trusts have the courage of having broad based Board of Directors (Trustees) of about 12-15 persons so that good constructive criticism an be received for improvement. The tradition of having Trust with family members and own employees should be abandoned. Trust meetings (or Board of Directors) should not be held ‘on paper by circulation’ for long time. Trustees should have the courage to face the reality. One of my friends who is a Trustee has suggested that all Trust should put their audited account on the website (if we have one) and convert the Trust to section 25 company for transparency. However, the last part of the suggestion is not very helpful as per personal observations. Trustees should learn to leave behind narrow personal interest and not to take wrong decision in whims and fancy at the cost of the blood bank. Trustees must respect opinion of technical persons working in blood banks. It is a fact that Trustees/ owners are paying salary to technical staff but without them Trustees/ owners cannot run blood bank activity/ business. Because, blood bank is a medical organization.
We are strongly in favor of continuing services of good NGO-run blood banks and many of them are even standalone blood banks. They have a better number of voluntary donations; they take prompt and proactive actions for blood safety and maintain better quality of components. However, it is important to have some control from the regulatory authority and State Blood Transfusion Councils on the administration of NGO-run blood banks. There should be a wider representation in the Trust (Board of Directors) and it should be constituted by about 15 members and there should not be more than two persons from the same family in the Trust. Please keep one of the technical persons from the blood bank as one of the members of the Trust so that they can express their opinion in the meetings of the Trust/ Board of Directors. Self-interests like nepotism, favoritism, monetary benefits and personal ambitions should be kept aside because NGOs are committed to serve the society. Trustees should follow the rule of self-discipline and let the Blood Bank Officer do his job. Only involve yourself for monitoring of blood bank performance at quarterly or half-yearly intervals or when there is a need to be associated with critical decision-making. Trustees should try to become a ‘referee’ of the game, they need not play the game.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2920472/
Drugs and Cosmetics Act
In accordance with the directive of the Supreme Court, NACO appointed an expert committee to revise the Drugs and Cosmetics Rules Pertaining to blood banking. After a series of meetings spanning over two years the amended Drugs and Cosmetics Rules virtually a total revision came into force with effect from April 5. 1999. The rules thereafter were modified thrice till 2003.
Under this act and its rules, no blood bank in the country can function without first obtaining license from the Central License Approving Authority of the Ministry of Health and Family Welfare on the basis of recommendation of Director, Drug Control of the state by abiding the condition laid down in the Act and the Rules. The license has to be renewed on expiry.
The most important point of this legal provision that the donor motivators should take note of is that blood from voluntary blood donor in out door camps can only be collected by:
A licensed Government Blood Bank,
Indian Red Cross Society,
A licensed Regional Transfusion Centre designated by State Blood Transfusion Council constituted by the State Government.
http://www.mahasbtc.com/index.php?option=com_content&task=view&id=93&Itemid=224
Law and Transfusion Service
Blood and blood components are categorised as a "drug" under Section 3(b) of Drugs and Cosmetics Act, 1940 because of their interna adminstarion. This Act and the Rules thereof provide the legal framework for regulating the functions of blood banks, which in turn directly irnpart and determine the quality of the blood transfusion service delivery in the- country. Since initial formalities, the ambit of the Drugs and Cosmetics Act1940, has been expanded and the Rules have frequently been amended to incorporate blood as drugs because of their internal administration and use in treating diseases. The transfusion of blood cells is also transplantation and cells must survive and function after transfusion in order to have therapeutic effect. As with drugs, adverse effects may occur due to blood transfusion. All these necessitates careful consideration and handling of service in accordance with the law of the land.
Article 21 under part III titled fundamental rights of the Constitution of India clearly spells out that no person shall be deprived of his life. Blood transfusion can be life saving and also can be fatal, therefore, comes under this section of fundamental rights. Besides under chapter XIV of the Indian Penal Code Section 269 provisions for fine and imprisonment for negligent act likely to spread infectious disease dangerous to life and section 270 of the Malignant Act likely to spread infection of disease dangerous to life covers blood transfusion and blood banking in all aspects.
Consumer Protection Act
Consumer Protection Act of 1986 came into force in July, 1987 for all goods and services, covers all sectors - private, public, cooperative etc It enshrines the six rights of the consumers:
Right to safety
Right to be informed
Right to choose
Right to be heard
Right to seek redressal
Right to consumer education.
The portions of the Act are compensatory in nature.
Supreme Court Directive
The Supreme Court on November 13, 1995 upheld the National Consumer Commission's judgement of April 1992, whereby patients who received deficient services from medical professions and hospitals are entitled to claim damages under this Act. Naturally, blood banking service comes under this Act and both donor and recipient may take the cover of this Act.
Public Interest Litigation
On a public interest litigation filed by a Delhi based organisation 'Common Cause' by a writ petition (civil) no 91 of 1992 under Article 32 of the Constitution of India, Hon'ble Justice S C Agarwal and Hon'ble Justice G B Pattanaik on January 4, 1996 issued the following directives:
The Union Government shall take steps to establish forthwith a National Council of Blood Transfusion as a society registered under the Societies Registration Act. It would be a representative body having in it representation from the Directorate General of Health Services of the Government of India, the Drug Controller of India, Ministry of Finance in the Government of India, Indian Red Cross Society, private blood banks including the Indian Association of the Blood Banks, major medical and health institutions of the country and non-Government organisation active in the field of securing voluntary blood donations. In order to ensure coordination with the activities of the National Aids Control Organisation, the Additional Secretary in the Ministry of Health, who is in charge of the operations of the programme of National Aids Control Organisation for strengthening the blood banking system could be the President of the National Council.
The National Council shall have a secretariat at Delhi under the charge of a Director.
The basic requirements of the funds for the functioning of the National Council shall be provided by the Government of India but the National Council shall be empowered to raise funds from various other sources including contributions from trade, industry and individuals.
In consultation with the National Council, the State Governments/ Union Territory Administration shall establish a State Council in each State/ Union Territory which shall be registered as society under the Societies Registration Act, The State Council should be a representative body having in it representation from Directorate of Health Services in the State, State Drug Controller, Department of Finance of the State Government/Union Territory Administration, important medical institutions in the State/Union Territory, Indian Red Cross Society, private blood banks, Non-Government Organisation active in the field of securing voluntary blood donations. The Secretary to the Government in charge of Department of Health could be the President of the State Council.
The State Council should have its headquarters at the premises of the premier medical institution or hospital in the State/Union Territory and should function under the charge of a Director.
The funds for the State Council shall be provided by the Union of India as well as the State Government/Union Territory Administration. The State Council shall also be empowered to collect funds in shape of contributions from trade, industry and individuals.
The programmes and activities of the National Council and the State Council shall cover the entire range of services related to operation and requirements of blood banks including the launching of effective motivation campaigns through utilisation of all media for stimulating voluntary blood donations, launching programmes of blood donation in educational institutions, among the labour, industry and trade, establishments and organisations of various services including civic bodies training of personnel in relation to all operations of blood collection, storage and utilising, separation of blood groups, proper labelling, proper storage and transport, quality control and archiving system, cross-matching of blood between donors and recipients, separation and storage of components of blood, and all the basic essential of the operations of blood banking.
The National Council shall undertake training programmes for training of technical personnel in various fields connected with the operation of blood banks.
The National Council shall establish an institution for conducting research in collection, processing, storage, distribution and transfusion of whole human blood and human blood components, manufacture of blood products and other allied fields.
The National Council shall take steps for starting special postgraduate courses in blood collection, processing, storage and transfusion and allied fields in various colleges and institutions in the country.
In order to facilitate the collection of funds for the National Council and the State Councils, the Government of India (Ministry of Health and Ministry of Finance] should find out ways and means to secure grant of 100% exemption from income tax to the donor in respect of donation made to the National Council and State Councils.
The Union Government and the Government of the States and Union Territories should ensure that within a period not more than one year all blood banks operating in the country are duly licensed and if a blood bank is found ill equipped for being licensed, and remains unlicensed after the expiry of the period of one year, its operations should be rendered impossible through suitable legal action.
The Union Government and the Governments of the States and Union Territories shall take steps to discourage the prevalent system of professional donors so that the system of professional donors is completely eliminated within a period of not more than two years.
The existing machinery for the enforcement of the provisions of the Act and the Rules should be strengthened and suitable action be taken in that regard on the basis of the scheme submitted by the Drugs Controller (I) to the Union Government for upgradation of the Drugs Control Organisation in the Centre and the States (Annexure II to the affidavit of Shri R Narayanaswami. Assistant Drug Controller, dated September 16,.1994. )
Necessary steps be taken to ensure that Drug inspectors duly trained in blood banking operations are posted in adequate numbers so as to ensure periodical checking of the operations of the blood banks throughout the country.
The Union Government should consider the advisability of enacting a separate legislation for regulating the collection, processing, storage, distribution and transportation of blood and the operation of blood banks in the country.
The Director General of Health Services in the Government of
India, Ministry of Health shall submit a report by July 15, 1996 about the action taken in pursuance of these directions.
It will be open to the Director General of Health Services, Government of India as well as the National Council to seek clarification/modification of these directions or further directions in this matter.
Drugs and Cosmetics Act
In accordance with the directive of the Supreme Court, NACO appointed an expert committee to revise the Drugs and Cosmetics Rules Pertaining to blood banking. After a series of meetings spanning over two years the amended Drugs and Cosmetics Rules virtually a total revision came into force with effect from April 5. 1999. The rules thereafter were modified thrice till 2003.
Under this act and its rules, no blood bank in the country can function without first obtaining license from the Central License Approving Authority of the Ministry of Health and Family Welfare on the basis of recommendation of Director, Drug Control of the state by abiding the condition laid down in the Act and the Rules. The license has to be renewed on expiry.
The most important point of this legal provision that the donor motivators should take note of is that blood from voluntary blood donor in out door camps can only be collected by:
A licensed Government Blood Bank,
Indian Red Cross Society,
A licensed Regional Transfusion Centre designated by State Blood Transfusion Council constituted by the State Government.
A Code of Ethics for Blood Donation and Transfusion formulated
by International Society of Blood Transfusion on July 12, 2000.
The objective of this code is to define the ethical principles and rules
to be observed in the field of Transfusion Medicine.
Blood donation including haematopoietic tissues for transplantation shall, in all circumstances, be voluntary and non-remunerated; no coercion should be brought to bear upon the donor. The donor should provide informed consent to the donation of blood or blood components and to the subsequent (legitimate) use of the blood by the transfusion service.
Patients should be informed of the known risks and benefits of blood transfusion and/or alternative therapies and have the right to accept
or refuse the procedure. Any valid advance directive should be respected.
In the event that the patient is unable to give prior informed consent, the basis for treatment by transfusion must be in the best interests of the patient.
A profit motive should not be the basis for the establishment and running of a blood service.
The donor should be advised of the risks connected with the procedure: the donor's health and safety must be protected. Any procedures relating to the administration to a donor of any substance for increasing the concentration of specific blood components should be in compliance with internationally accepted standards.
Anonymity between donor and recipient must be ensured except in special situations and the confidentiality of donor information assured.
The donor should understand the risks to others of donating infected blood and his or her ethical responsibility to the recipient.
Blood donation must be based on regularly reviewed medical selection criteria and not entail discrimination of any kind, including gender, race, nationality or religion. Neither donor nor potential recipient has the right to require that any such discrimination be practised.
Blood must be collected under the overall responsibility of a suitably qualified, registered medical practitioner.
All matters related to whole blood donation and haemapheresis should be in compliance with appropriately defined and internationally accepted standards.
Donors and recipients should be informed if they have been harmed.
Transfusion therapy must be given under the overall responsibiliiy of a registered medical practitioner.
Genuine clinical need should be the only basis for transfusion therapy.
There should be no financial incentive to prescribe a blood transfusion.
Blood is a public resource and access should not be restricted.
As far as possible the patient should receive only those particular components (cells, plasma, or plasma derivatives) that are clinically appropriate and afford optimal safety.
Wastage should be avoided in order to safeguard the interests of all potential recipients and the donor.
Blood transfusion practices established by national or intemational health bodies and other agencies competent and authorised to do so should be in compliance with this code of ethics.
