Express Healthcare garners views from industry experts on the accreditation guidelines for blood banks in India. They also highlight the areas where we lag in terms of blood safety measures
All blood banks should be encouraged to go for NABH accreditation. Abiding by the guidelines laid out by NABH will automatically ensure quality and safety of blood. This will also ensure much better patient safety. The most important aspects to be considered:
- Encourage repeat voluntary donors: The more the number of times a person has donated blood, it’s directly proportional to safe blood. Most of the times, we have first time voluntary donors. This also means we need to have more awareness programmes held for people to donate further. The benefits of blood donation should be highlighted better.
- Pre-donation counselling: Whenever a person is readied to donate, the donor medical history should be noted down well. There should be a good counselling session provided to the donor to fish out any medical problems he or she is facing. This is a very important exercise.
- Proper use of blood and blood components: It is necessary to administer the right amount of blood or blood components to a patient. Indiscriminate use of blood products should be curtailed.
- Proper EIA testing should be undertaken.
- NAT Testing: Once NAT testing is administered, rest assured you have received the best blood. Hinduja Hospital is one of the early adopters to NAT testing.
– Dr Anand Deshpande, Consultant Transfusion Medicine & Hematology, PD Hinduja Hospital & MRC
Blood transfusion is one of the necessary modalities in patient care. Blood is a biological material and carries inherent risks. Blood transfusion is ‘error-prone’ by virtue of the process involving a chain of events done at different locations, by different personnel, happening simultaneously or in series. Some errors can be life threatening.
‘Accreditation Canada’ defines patient safety as ‘prevention and mitigation of unsafe acts within healthcare system’.
Blood is a ‘drug’ and hence covered in India under Drugs and Cosmetic Act. The law has framed stringent requirements to operate a blood bank. By providing technical requirements like premises, personnel, equipment, QC, etc., it mandates conformance to standards of strength, quality or purity.
Regulatory standards state what is required to operate a blood bank, whereas accreditation standards elaborate on how to achieve quality and safety in a product/ service.
In India, accreditation standards were developed systematically i.e. National Blood Policy (2003), Standards for Blood Banks by NACO (2007), Accreditation Standards for Blood Banks and Transfusion Services by NABH (2007). Accreditation standards cover technical as well as quality requirements, and span its scope to the clinical side of transfusion. This was a major step to assure safety in blood transfusion.
Accreditation standards in India are comparable to those of well established accreditating bodies world over. Emphasis is on continual quality improvement. Apart from technical requirements, standards demand conformance to quality aspects like training, supplier evaluation, documentation, records, and more importantly on performance improvement through internal audits, CAPA, and management reviews, etc.
A well developed system based on accreditation standards can ensure top-notch quality and safety.
– Dr Rajeev Nikte, HOD-Blood Bank, Global Hospitals, Mumbai
The blood banking practice in Maharashtra is under the guidelines and control of the FDA and they have certainly laid down stringent policies. They are adequate to prevent any problems with blood banking.
The assessment of blood in the window period can be improved by NET testing. There is a high possibility of infection in the window period. It has not been mandatory till now for the assessment of blood in the window period and hence infection is missed during the incubation period. So, it has to be made mandatory for assessment of blood in the window period.
– Dr Vijay D’Silva, Director – Medical Affairs & Critical Care, Asian Heart Institute, Mumbai
The recent guidelines by NACO for medical officers and lab technicians and separately for nurses are by and large appear to be adequate.
We have around 2609 blood banks across India in different sectors such as government hospitals, private hospitals, trust run banks and private standalone blood banks of which around 100-110 are accreditated. We have the NACO, QCI and NABH which have laid down adequate guidelines; however governance is a huge problem.
We lag in terms of commitment, type of blood bankers, intentions and mentality of the receivers and the customers’ i.e. doctors, needs to be addressed.
I have noticed that implementation of these guidelines are different in various blood banks. Moreover, at many blood banks nearly 40 per cent of the standards for blood safety is not been met. If you take a look at the government hospitals, the methods for blood grouping is not up to the standards.
Additionally, there are many blood banks that still use the manual methods which should be avoided. Automation in blood banking has reduced errors; however this needs to be further reduced.
– Dr Mahendra Singh Chauhan, HOD – Dattaji Bhale Blood Bank, Dr Hedgewar Hospital, Aurangabad
Our guidelines are comparable to global standards; however, where we fall short when it comes to good monitoring mechanisms. We also see a huge disparity between blood banks in the urban areas and those at district levels. Laws regarding blood transfusion services are part of Drugs and Cosmetics Act. Blood is under the regulatory control of Drug Controller (General) of India, the Central licensing authority which is assisted by the State Drug Controllers. The NBTC and SBTC are advisory in nature. Despite availability of consensus guidelines inappropriate blood transfusions happen, and not all collected units are converted into components, reporting of adverse events after transfusion is poor and donor deferral system is practically nonexistent. So, despite multiple agencies there is poor monitoring and control. We should consider a single autonomous agency manned by people with experience in transfusion medicine.
The biggest challenge is a steady supply of safe blood. Also, recruitment of voluntary donors who are committed and will be repeat donors. Information, communication, and education to first time donors, so that they overcome their fears and prejudices cost a lot in terms of time, effort and funds, which are often scarce. There is unfortunately no centralised system to co-ordinate services and stocks so the deficit can be anywhere between 20-40 per cent. It also leads to wastage of blood or components in a few setups.
The control on pricing deters the industry from implementing latest technologies as the cost implications would be high. We also need to find ways to increase longevity of blood and at the same time ensure that the clinicians are willing to accept that blood.
– Dr Charu Pamnani, Head – Laboratory Medicine and Quality for Wockhardt Hospital
The accreditation guidelines for the blood banks are adequately framed, but for blood safety we lack our focus on getting a safe donor. Pre-donation counselling of the blood donors is not carried out, blood donors are not adequately educated on the various illnesses and diseases that can be transmitted through blood so that they can go in for self deferral. They should be made to understand their responsibility in answering the donor questionnaire honestly.
Therefore, safety will remain a concern until and unless we get truthful and honest replies from the donors about their lifestyle and the illnesses they have suffered. This is only possible if they have been counselled before blood donation.
A number of tests are now available which intend to reduce the window period of the infections. But until and unless proper counselling of the blood donors is done prior to blood donation it is not possible to increase blood safety. Accreditation guidelines are laid down and mandatory but how much of it is actually followed and done remains to be seen.
– Dr Narinder Naidu, Medical Director, Indian Red Cross Society
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