Bangalore Medical Services Trust Bangalore, Karnataka, India
Background/Case Studies: AABB has developed fundamental standards for quality certificate which is specially meant for developing countries like India. Asian Association of Transfusion Medicine (AATM) joined hands with AABB to implement quality certificate program in Asian countries. This Regional Blood center in South India participated in the first pilot project to implement fundamental standards. This study is planned to review the process of certification in order to help other centers. Also to measure the impact on regular blood bank processes as well as to compare the standards with Indian Accreditation standards (National Accreditation Board of Hospitals & Health care providers/NABH) which is based on ISO-15189.
Study
Design/Methods: We reviewed the entire process of Quality certificate and analyze some parameters like: time duration, man power involved, financial burden, changes in documents and non-conformities given by the AABB assessor. We also compared the standards with NABH standards and evaluate the impact of this achievement of our services.
Results/Findings: In October 2020, after going through the AABB fundamental standards, first we did a gap analysis. After discussion with AABB team we started providing our responses to each clause as well as the supporting documents. These were reviewed by the AABB assessor. It took nearly 120 days to us but we realized it can be achieved in 90 days too. This involved two staff members who spent 10 hours every week to work on the program with NO extra financial burden to the blood center. We had 18 non conformities: 15 were in chapter 5 process control and 3 others. We performed immediate remedial action as well as root cause analysis and corrective action plans were submitted. Out of 18, the root cause was “insufficient documentation” in 13 where change in documentation was done. We found 5 NCs were “policy/process change” required: like there was no look back policy in case of TTI detected as well as no review of donor’s previous information and review of patient’s clinical history was done. When we compared the standards of NABH Accreditation and AABB Certificate, we found three areas with major differences: detailed documentation about computer system including backup & the downtime (not in NABH), labeling of blood units and the review of historical information of donor and patients has been given more emphasis in AABB then NABH. Conclusions: We concluded that AABB Quality certificate helps in improving services as well as documentation with no extra financial burden. It gives the privilege of an international assessment by a reputed time tested accreditation body. We understand India has blood bank accreditation program but many Asian countries do not have that. Even then the BTS is fragmented and with huge differences in services. AABB Quality certificate will bring standardization in the services and will also help in upgrading the technical and quality matters.
Importance of research: This study is planned to review the process of certification in order to help other centers. Also to measure the impact on regular blood bank processes as well as to compare the standards with Indian Accreditation standards (National Accreditation Board of Hospitals & Health care providers/NABH) which is based on ISO-15189.
