Dr Bhupendra Kumar Rana, Joint Director-NABH, Quality Council of India; and Chairman- ISQua Accreditation Council details the measures needed to get NABH accreditation for blood banks and elaborates on the best practices to be implemented for enhancing blood banks standards in the country, in an interaction with Lakshmipriya Nair
What measures should be implemented to get blood bank accreditation?
NABH accreditation standards for blood banks/ centres and transfusion services are divided into eleven clauses and each clause has been further divided into several sub-clauses. They are as follows:
- Organisation and management: The blood bank/ blood centre should be a legal identity and must have a valid license from the Central Drugs Standard Control Organization (CDSCO) and approval by the Drug Controller General (India). The blood bank is required to define its organisational structure in terms of various positions and their functions.
- Accommodation and environment: The premises, used for the operation of a blood bank/ blood centre and/or preparation of blood components should be constructed in such a manner so as to permit the operation of the blood bank/ blood centre and preparation of blood components under hygienic conditions and should avoid entry of insects, rodents and flies. It should be well-lighted and ventilated. The blood bank/ blood centre should be designed for the efficiency of its operation, to optimise the comfort of its occupants and to minimise the risk of injury and occupational illness.
- Personnel: The blood bank/ blood centre is required to employ an adequate number of individuals qualified by education, training and experience. Its operation should be conducted under the active direction and personal supervision of competent technical staff. Qualification and experience for Director/ in-charge/ medical officer/ in-charge, supervisors, technicians and nurses must be at the minimum as required by the licensing authority.
- Equipment: The blood centre must be in the possession of all the equipment required for blood collection, component preparation, processing, examination and storage, appropriate as per the scope of licence. It is a must that equipment are properly calibrated, maintained, and monitored for their functioning and kept in a clean and proper manner and so placed as to facilitate regular cleaning and maintenance. To protect the equipment from damage and improper use, only authorised personnel should operate them.
- External services and supplies: There must be documented policies and procedures for the selection and use of purchased external services, equipment and consumable supplies that affect the quality of its services. There should be procedures and criteria for inspection and acceptance/ rejection of consumable materials. All supplies and reagents used in the collection, processing, compatibility testing, storage and distribution of blood and blood components should be stored at a proper temperature in a safe and hygienic place. A proper inventory control system should be in place.
- Process control: The blood bank/ blood centre is required to have policies, processes and procedures to ensure the quality of the blood, component, derivatives and services, and ensure that these policies, processes and procedures are carried out under controlled conditions. There should be a mechanism to identify who performed each critical step in collection, processing, compatibility testing and transportation of blood, component and derivatives issued, and when it was performed.
- Identification of deviations and adverse events: The blood bank/blood centre is required to implement a defined policy and procedure when any aspect of its test analysis or function does not conform to laid down procedure. It allows blood bank to identify deviation, if any, caused in its operations and take necessary measures.
- Performance improvement: The blood bank/blood centre must put a policy and procedure in place for addressing complaints, or other feed backs received from donors, clinicians, blood camp organisers or other parties. These can be used as improvement tools.
- Document control: Blood bank/ blood centre must define document and maintain procedures to control all documents and information (from internal and external sources) that form its quality documentation.
- Records: All records relevant to the quality management system are uniquely identified and appropriately labelled. Policies, processes and procedures to ensure that records are identified, reviewed, retained and that records are created, stored, and archived in accordance with record retention policies
- Internal audit and management review: Management review and internal audits of all elements of the system, both managerial and technical, is to be conducted at regular intervals but not less than once in twelve months in order to verify that operations continue to comply with the requirements of the quality management system.
How can quality standards be maintained post-accreditation?
Accreditation is usually based on self-governance and improvement. It should not be subjected to policing, however to ensure that accredited blood bank continuously comply with the accreditation requirements, regular surveillance at mid cycle i.e. between 15-18 months of accreditation is conducted. Further, there is a provision of surprise checks conducted on randomly selected accredited organisations including blood banks. Each month, one facility is selected for such checks. Special visits may be conducted based on complaints or reports.
NABH has recently defined following ten quality indicators for blood banks to monitor. Of these, first five are mandatory to monitor and report to NABH every six months. It will help NABH and blood banks to keep an eye on improvement being demonstrated and compliance to standards.
- TTI rate
- Adverse transfusion reaction rate
- Wastage rates
- Turnaround time (TAT) of blood issues
- Component QC failures (for each component)
- Adverse donor reaction rate
- Donor deferral rate
- Percentage of components
- TTI outliers percentage
- Delays in transfusion beyond 30 minutes after issue- sample audit by BB every month.
How can policy makers better blood bank practices?
Blood banks needs to be licensed before starting its operations, therefore, strong regulatory regime i.e. licensing is important to ensure compliance to minimum requirements in terms of structures and some processes as laid out in D and C Act. Accreditation can play an important role in ensuring high quality and safety in blood bank practices. Policy makers should make use of accreditation to ensure high quality and safety in blood bank practices. Policy makers can make it happen by promoting importance of safe blood amongst blood banks.
What is the need of the hour for Indian blood banks?
There is an immediate need to improve services at blood banks. Despite many claims, there are reports regarding lack of availability of required blood, wrong transfusion of blood to patient as well as infected blood. It is important that efforts are taken to increase the availability of blood by promoting voluntary donations. Proper use of blood is essential as one unit of blood may be used for more than one patient if its components are prepared. It is also seen that at times wrong blood group is transfused, leading to catastrophic incidents. Some times the blood is not properly tested for essential parameters e.g. HIV, HCV, malaria etc. and if transmitted to a patient, results may be deadly. The commitment of the management to provide safe blood and adopting safe transfusion practices is critical and essential area to give importance to improve standards.
How can NABH encourage blood banks to get accreditated?
There are 69 blood banks accredited by NABH in India. Being a voluntary process, it is very difficult to rope in blood banks. However, NABH has drawn a strategy to bring more and more blood banks under its accreditation programme. This includes conducting awareness programmes, organising three days programme on implementation and liaising with National AIDS Control Organisation (NACO), Ministry of Health, Government of India. In addition, we try to encourage blood banks through our experts/ assessors who communicate with blood banks on the benefits of accreditation.