Following the devolution of the health sector in June 2011 under the 18th constitutional amendment, the Islamabad Blood Transfusion Authority was revived by the Ministry of National Health Services, Regulation & Coordination in September 2013. A new Chairman and an Advisory Board were also notified. The revived IBTA developed a plan of action which laid out the framework of the scope of activities including; development of an evaluation tool for inspection of the blood banks, formation of a pool of eminent experts to act as IBTA inspectors, announcements in the press for applications for registration and licensing, processing of applications and organizing the initial, routine, surprise and annual inspections as well as conducting regular capacity building activities. Currently 19 blood banks have been granted licenses following successful inspections (in some cases after more than one inspection) and six blood establishments have been closed down due to poor standards. Two blood banks are only registered and not licensed. Two initially licensed blood banks are currently on probation.
Data collection, management, analysis and its publication is the responsibility of blood regulatory authority. This is essential for improved planning and evaluation of services. IBTA collects the annual data from all its licensed blood banks regularly in the month of January every year. This year also the licensed blood banks submitted their 2018 data on the prescribed form to the IBTA. The compliance was 100% and within the prescribed four weeks period.
In contrast to pre-2013 period, most of the blood screening in ICT is now conducted on automated systems based on NAT, CLIA and ELISA technology. Automation has been actively promoted by IBTA during the last five years and screening of 99% of blood collected in Islamabad on good quality automated technology has strengthened the weakest link of the vein-to-vein blood transfusion. This is an encouraging finding as automation and use of quality kits on advanced sophisticated equipment ensures better safety standards. All licensed blood banks reported 100% testing for HIV, Hepatitis B and C infections, Malaria and Syphilis. In 2014, about 25% of the total donations were screened for Syphilis and Malaria. This rate increased to about 46% in 2015 and to about 60% in 2016, 77% in 2017 and finally 100% in 2018 as a result of continuous advocacy and effective regulation by IBTA.
Facilities for component production and storage have been made mandatory by the IBTA for licensing since 2014. Nearly 99% of the blood units collected in ICT are now separated into at least three blood components which were much less in previous years. This is in stark contrast to the practice in the rest of the country where only about 40% of the collections are processed into blood components. In many centres across the country despite having the required equipment, manpower and resources not all whole blood donations collected are processed mainly due to physician preference for ‘fresh whole blood’.
The documentation standards have improved considerably as a result of the IBTA advocacy and the mandatory requirement of sharing the annual data. Now all ICT blood banks use uniform blood component issuance forms developed by the Authority. This time the IBTA collected data about donor deferral in the year 2018 which indicated that about 6.8% of the blood donors who presented for blood donations were found unfit for donations, temporarily or permanently. Permanent deferrals were usually due to TTI reactivity while anaemia and low body weight were the main causes of temporary deferral. Knowledge of the reasons for donor deferral can help in planning effective donor recruitment and retention campaigns aiming at the availability of safe donors. The IBTA had introduced the internationally recommended AE (Adverse Event) and AR (Adverse Reaction) reporting system in the year 2016. The IBTA in collaboration with SBTP has also updated the National Quality Control Guidelines and the new reporting forms have been added to these guidelines which were shared with the blood banks and trainings conducted on the new reporting system. It is thus expected that improved quality of haemovigilance data will be generated in 2019.
The IBTA continued with the coordination and strengthening of the provincial blood transfusion authorities in 2018. The Islamabad BTA has also developed a model regulatory system over the last five years which is well suited to the national needs and is functioning quite effectively. The IBTA also coordinates with the provincial counterparts and has strengthened their capacity. The IBTA efforts are widely appreciated by the national stakeholders, provinces and also the international partners. The World Health Organization has recommended the Pakistan BT regulation model to the regional countries. The roadmap IBTA followed was very structured and systematic and had a huge impact on the quality of blood transfusion services in the federal capital. The inspection checklist is also being revised by the IBTA ‘Task Force on Regulation’ including eminent national experts. The first meeting of the task force is being organized in January 2019. The IBTA plans to generate real time data of the licensed blood banks on the IBTA website. All the licensed blood banks will be provided a link through which they can update their blood inventory status online on the IBTA website. The IBTA is continuously coordinating with the provincial BTAs and it is expected that these efforts will result in further strengthening of the regulatory authorities in the provinces. Proper operationalization of the provincial BTAs and their capacity building by the IBTA will go a long way in reducing the gap in the regulatory standards between the federal capital and the rest of the country.
Prof. Hasan Abbas Zaheer, PhD
Islamabad Blood Transfusion Authority
Ministry of National Health Services, Regulations & Coordination