|Year : 2016 | Volume
| Issue : 1 | Page : 29-31
Impact of regulation of blood transfusion services in Islamabad, Pakistan
Hasan Abbas Zaheer, Usman Waheed
From the Islamabad Blood Transfusion Authority, Ministry of National Health Services, Government of , Islamabad, Pakistan
|Date of Web Publication||3-Mar-2016|
Hasan Abbas Zaheer
From the Islamabad Blood Transfusion Authority, Ministry of National Health Services, Government of Pakistan, Islamabad
Source of Support: None, Conflict of Interest: None
The strengthening of the regulatory authorities is the backbone of the blood safety systems reforms being implemented in Pakistan. One of the key elements of this reform process is the re-activation of blood transfusion authorities (BTAs) to guide and steer the overall development of the blood sector in Pakistan. The success of these efforts will also help fulfill the government's international commitment in achieving the millennium development goals. The revived Islamabad BTA has in a very short time developed a very successful model of regulation based on constructive nonpunitive approach. A database of facilities providing blood services in Islamabad has been created, their registration and licensing completed and a system of regular inspections and re-inspections developed and capacity building of the technical and management staff conducted. In addition, as a result of strict adherence to the minimum licensing criteria, the standard of practices, equipment, manpower, and financial resource allocations of the blood centers in Islamabad have improved significantly in the public as well as the private sector. The successful demonstration of a practical model of regulation best suited to the prevailing scenario in Pakistan has provided a framework which will be followed in all confederating units through the provincial authorities.
Keywords: Authority, blood, Pakistan, regulation
|How to cite this article:|
Zaheer HA, Waheed U. Impact of regulation of blood transfusion services in Islamabad, Pakistan. Glob J Transfus Med 2016;1:29-31
| Introduction|| |
Empowered and effective regulatory system is an essential prerequisite for an efficient and reliable blood transfusion service. The regulation of blood sector implies enactment and enforcement of laws and rules by the government for safe blood transfusion practices. It indicates how the system is implementing the policies, strategies, goals, and objectives. Islamabad, the capital of Pakistan, has an estimated population of two million. Compared to the other parts of the country, Islamabad has an improved healthcare infrastructure.
In Pakistan, during the period 1997–2004, all the provinces and states passed their respective legislation on blood safety. For the federal capital, the Ministry of Health got promulgated the blood safety ordinance in 2002, to regulate the transfusion of safe blood and blood products in Islamabad. Through the ordinance, the Islamabad Blood Transfusion Authority (IBTA) was constituted by the Federal Government in 2005, followed by the formulation of “IBTA Rules of Business” through a Statutory Regulatory Orders of the Ministry of Health in April 2005. Following the devolution of the health sector in 2011 under the 18th constitutional amendment, the authority was revived by the Ministry of National Health Services Regulation and Coordination (NHSR and C) in September 2013, and a new chairperson and a new advisory board were also notified.
The IBTA is also coordinating with the BTAs of the various provinces and states of Pakistan to provide assistance through provision of technical tools for blood banks inspection including inspection checklist, data collection form, template of the license, and adverse reporting format. The IBTA team also coordinated and participated in the inspections of blood banks in these regions.
| Materials and Methods|| |
The revived IBTA developed a plan of action which laid out the framework of the scope of activities and the development of an inspection tool for the inspection of the blood banks. The inspection tool consisted of questions related to blood banking operations and was made objective with close-ended questions to ensure neutrality. The inspection tool prepared was pretested in two blood banks functioning outside the territorial jurisdiction of IBTA, revised accordingly and announcements published in the press for registration and licensing of blood banks. Eminent experts from Islamabad were identified as IBTA inspectors.
An Inspection Preparatory Workshop  for the blood banks was organized to sensitize and prepare the blood banks for the IBTA inspections. Majority of the blood banks were either fearful or reluctant to have their blood banks inspected but effective advocacy and technical guidance from IBTA prepared them for the regulatory exercise. After the inspections, respective blood banks were informed about their manpower, equipment, and practice deficiencies. The response from most of the blood banks was encouraging and they invested considerable resources to fulfill their deficiencies and upgraded their centers to fulfill the licensing requirements. Later in the year, another capacity building workshop was organized  to train and equip the blood bank technicians and managers with the data management tools as the poor data management, and documentation was the most common deficiency observed during the inspection visits.
A collection of data from the blood banks was carried out to review the situation and status of different aspects of blood transfusion services in the blood banks in Islamabad, individually and collectively. The data were gathered through a pretested questionnaire based on the questionnaire by WHO Global Database on Blood Safety  which was adapted to the local requirements.
| Results|| |
Inspections of 23 blood banks have been conducted so far and licenses granted to 16 successful blood banks, three blood banks were placed on probation (to improve their deficiencies) while four have been closed down. Initially, some blood banks were apprehensive, fearing closure or penalties, but all the blood banks extended cooperation to ensure conduction of inspections.
Before the revival of the IBTA, the blood transfusion services in the Islamabad were unregulated and unchecked. The service structure was dominated by “blood banks” located within the public or private sector hospitals as stand-alone blood banks or as part of a pathology laboratory. These blood banks provided transfusion services, without any regulatory oversight, which fostered whole blood approaches, while donor management largely remained “outsourced” to the patient's family, requiring them to provide “replacement” donors. Blood banks were managed alternatively by medical officers or pathologists as blood bank services are often provided through general pathology laboratories. Some blood banks were functioning without any medical leadership, qualified or otherwise. The situation was similar for the technical laboratory personnel also. The prescription of whole blood was widespread and no uniform guidelines were followed. The documentation system was not consistent and no coherent, centralized system in place for data collection, transmission, reporting, and evaluation. Chronic blood shortages were a norm in the hospitals. In most of the cases, this was not really a “shortage” because of lack of rationale use of blood and blood components.
Staff levels for daily operation were not optimal in numbers for daily routine work in most blood banks, although laboratory supervision was well established (hematologists, pathologists, biochemists, etc.,) in the public as well as the private sector. Most of the blood banks were situated in sufficient sized laboratories. However, in all laboratories, the floors were made of tiles and cement which causes issues related to hygiene maintenance because blood and plasma may be absorbed by the cement. Generators were available in all blood banks, but UPS systems were installed on critical equipment only in a few blood banks. This may be attributed to low workload in majority of the blood banks.
In many cases, the quarantined products and products to be issued were stored in the same refrigerators or freezers. In the screening sections, most of the centrifuges used for tubes are too small for adequate spinning of collected tubes to separate plasma from whole blood. Predonation testing before whole blood collection is performed in some blood banks. The reason cited is to avoid wastage of blood but at the same time compromising the screening technology as the predonation screening is invariably performed on rapid devices.
The quality of blood grouping techniques was not satisfactory and slide technique was widely used for donor and patient testing. Only seven blood banks used the antihuman globulin technique for detecting incomplete antibodies. Only five laboratories check negative test results of indirect antiglobulin tests with sensitized red cells (Coombs control cells). Most of the centers write unit numbers, ABO and Rhesus D on the blood bag label but omit the expiry date. Labels fixed on blood products can be used for identifying not only the blood products but also provide a visual aim for identifying quarantine products.
Standard operating procedures (SOPs) are widely available in the blood banks but not utilized by laboratory staff. In some blood banks, the practice of handling tubes and blood bags was different compared to written instructions. Only two blood banks had equipment operating procedures and maintenance forms for use of cleaning, maintenance, and service. Handbooks and service manuals are not available nor any training records of laboratory staff.
| Discussion|| |
As the blood bank inspections progressed, the impact of inspections became clearly visible in the blood banks and many quality features were installed in the routine operations of the blood banks. The blood banks initiated donor and patient vigilance, developed quality control systems, improved documentation, biosafety, and waste disposal systems, and initiated procedures such as reverse grouping. The constructive approach of the IBTA inspectors helped in the development of the technical capacities of the blood bank staff and injected a sense of pride and professionalism among them. Adherence to SOPs, manuals, guidelines, etc., is not in vogue in most of the laboratory settings in the country. The utilization of the operational tools provided by BTA was thus a welcome outcome of the IBTA endeavor to introduce good laboratory and manufacturing practices.
The data collection, analysis, and interpretation for specific performance measures allow the decision makers to identify where systems are weak and pinpoint corrective adjustments and to track outcomes. The compliance for data collection has been 100% from the blood banks in Islamabad. The analysis  of the data collected indicates that many existing blood banks do not justify their existence as their workload is insufficient to justify their existence. This evidence thus supports the Safe Blood Transfusion Programme policy and concept of Regional Blood Centers (production units) and Hospital Blood Banks (consumption units). Nearly 75% of the blood collected using immunochromatographic tests (ICTs) in 2014 was from three hospital blood banks (two in the public sector and one in the private sector) while the remaining 25% collections are done by 16 blood banks. This underscores the need for development of a centralized model of service delivery. Centralization is not only economical but also promotes blood safety. In addition, duplication and wastages inherent in the current fragmented system can also be prevented if the centralized model is adopted.
For blood donations, the data indicate complete reliance on replacement blood donors (91%) except a couple of centers. The wastage of blood was another common finding in many small blood banks who discard up to 40% of their blood due to expiry. This also indicated the lack of coordination among the various blood banks operating in the ICT. Regarding the serological screening methodologies, majority of the blood banks in ICT utilize automated CLIA and ELISA technology and only a few smaller blood banks rely on manual rapid testing. This was an encouraging finding as automation and use of quality kits on advanced sophisticated equipment ensures better safety standards. Facilities for component production and storage were made mandatory for issuance of license. Many blood banks did not have these facilities and were therefore put on probation pending acquisition of the missing equipment and initiation of component production routinely. Therefore, during 2014, many blood banks invested heavily and procured the equipment required. Moreover, by the end of the year, more than 90% of the blood units collected in ICT was now separated into three blood components. This is in stark contrast to the practice in the rest of the country where processing of blood is not the norm in many centers.
The documentation standards have also improved as a result of the IBTA efforts, and now, all ICT blood banks have started using uniform forms provided by the authority. Notification of hospital transfusion committee has also been made mandatory for licensing, and the same have now been notified and made functional in all ICT blood banks. Minutes of HTC meetings are regularly provided to the authority. Through the HTCs, hemovigilance systems have been established in all blood banks, and this development will help ensure better transfusion outcomes and generate evidence-based data and recommendations for improvement.
| Conclusion|| |
The authority has shown significant improvement in the last 1 year with very limited resources. It is expected that with the strengthening of the provincial BTAs, the standard of service delivery will improve and blood safety and accessibility will be enhanced. To achieve this objective, the IBTA plans to hold a National Consultation on Blood Regulation, which will include the national health leadership, Ministry of NHSR and C, Provincial Blood Transfusion Programmes and BTAs, Departments of Health, and stakeholders from nongovernment organization/private sector establishments. The consultation will disseminate the achievements of the revived BTAs and advocate the role of regulatory bodies in blood transfusion sector sensitizing the policy makers to continue their commitment to strengthen the transfusion sector in the country and successfully implement the government's blood safety systems reforms.
Financial Support and Sponsorship
IBTA, Ministry of National Health Services, Government of Pakistan.
Conflicts of Interest
There are no conflicts of interest.
| References|| |
Zaheer HA, Waheed U. Legislative reforms of the blood transfusion system in Pakistan. Transfus Med 2014;24:117-9.
The Gazette of Pakistan. Islamabad Transfusion of Safe Blood Ordinance, 2002. Ministry of Law, Justice, Human Rights and Parliamentary Affairs, Law, Justice and Human Rights Division, Government of Pakistan; 2002. Available from: . [Last accessed on 2015 Mar 20].
The Gazette of Pakistan. Islamabad Transfusion of Safe Blood Rules, 2005. SR0 307 (1) 12005, Ministry of Health, Government of Pakistan; 2005.
Islamabad Blood Transfusion Authority. Report on Preparatory Workshop for Registration and Licensing of ICT Blood Banks; 2014. Available from: . [Last accessed on 2015 Mar 19].
World Health Organization. Global Database on Blood Safety; 2013. Available from: .