Academic Institute IDTM, University of Groningen, NL - 2005
PAKISTAN NACP-FHI PROJECT REPORT
DEVELOPMENT OF QUALITY ASSURANCE SYSTEM FOR THE OPERATIONS OF BLOOD TRANSFUSION SERVICES IN PAKISTAN
Date 06 – 20 February 2005
Place NACP at NIH, Islamabad, Pakistan
Consultant Prof. Dr. Cees Th. Smit Sibinga, FRCP Edin, FRCPath
Academic Institute IDTM[1]
Groningen, NL
Objectives -
The main objective of the consultancy is to ensure the ‘operationalization’ and appropriate implementation of a Quality Assurance Programme that ensures the availability of high quality blood and blood components for transfusion with maximum efficacy and cost-effectiveness and minimum risk to both the donors and recipients. The desired quality management system should aim at:
Implementation of standardized methods for identification, preparation, storage, handling and testing of blood and blood components;
Ensuring maximum detection of significant in-vitro donor-recipient incompatibility;
Ensuring minimum donor variability;
Maximum effectiveness of the Blood Transfusion Systems.
Expected outcomes –
Development of Quality Management System along with all relevant supplementary materials
Comprehensive report encompassing situation analysis, objectives, methodology, detailed description of the system and relevant material as annexes
Standardized QMS for BT in place and ‘operationalized’[2]
EXECUTIVE SUMMARY
Although there was some modest movement noticed, the major shortcomings and problem areas observed do not differ from those mentioned in the reports of prevision missions (1984 – 2002) as undertaken by Dr. Fereydoun A. Ala, Dr. Janet Merza and the WHO EMRO teams (Dr. Nabila Metwali, Dr. Guy Levi and Dr. Luc Noel) and are:
1. Lack of awareness, commitment and initiative at all levels;
2. Defined national policy and strategies not activated;
3. Legislation (Ordinances) and regulations (notifications) inadequate;
4. No adequate budget allocated for a safe and sustainable blood supply system;
As a consequence there is -
1. Absence of a reliable and healthy donor base and registry (voluntary, non-remunerated and regular);
2. Absence of proper organisation and management of the blood supply system; highly fragmented, non-professional and full of risk for donors, personnel and patients;
3. Absence of comprehension of the quality concept and quality thinking; no quality system and quality management (standards, documentation, traceability, proper quality control and assurance);
4. Absence of adequate and universal (nation wide) access to safe, efficacious and affordable blood supply;
5. Absence of equity (human right) in delivery of safe and efficacious blood components and supportive haemotherapy;
6. Absence of appropriate and rational clinical use of blood and blood components, where the majority of prescribing clinicians are not familiar at all with the principles of haemotherapy;
7. Absence of technical efficiency and quality of the blood supply services, both donor and recipient oriented.
8. Absence of cleanliness and hygiene, no maintenance of equipment and facilities;
9. In most situations observed there are absolutely inadequate facilities: too small, crowded, inappropriate flow of donors, material supplies and blood, no entrance restrictions, mostly old, dirty and non-functioning equipment (no maintenance), lack of valid reagents and storage capacity, highly unsafe waste management, inappropriate to complete absence of documentation and archiving (no traceability).
10. Despite the recent investment a selected group of potential quality managers, these people have not been stimulated or have even been discouraged, to spread their knowledge and expertise amongst colleagues. Some have attempted to implement, others not. The comprehension of the quality concept in particular in relation to the vein to vein blood transfusion chain of the majority of them has not demonstrably increased.
General comments –
In isolated situations some progress was noticed, as well as potential leadership and awareness. Only a few hospital and NGO blood banks have taken modest action based on earlier observations and initiated some improvement. However, the majority did not show any improvement at all. This is specifically true for the professionals in the public sector – attitude has not changed and understanding and awareness of the necessary quality culture are still virtually absent to rudimentary.
There is a lot of latent resistance and ‘cutting corners’ arguments on the change of the current system noticed in all BTUs visited - inconsistent supply of reagents and blood bags, inconsistent performance of all processes and procedures, inconsistent manual and duplicating documentation, no proper traceability (cumbersome and painstaking due to the many different ‘registers’ in books), poor communication, no confirmatory testing in place.
At Provincial Government level there is insufficient information and awareness on the real urgency of the situation.
Staff continued to function in a non-responsible way, ignoring basic principles of hygiene and cleanliness, no professional pride or interest, no initiative or professional curiosity; lack of leadership.
To develop a Plan of Action for Quality Assurance[3] and Quality Management[4] in the current Blood Transfusion Services/Blood Units one has to start with the human resource – education through involvement and commitment, creating the feeling of ownership and raise genuine professional interest. Assurance and management can only be developed if there is a system to assure and manage.
In Pakistan such system in virtually non-existing for blood transfusion, although clear recommendations and an indicative Plan of Action were provided, discussed and excepted to develop such system in compliance with both basic principles of Human Rights and the international WHO and IRCC recommendations[5].
Therefore, the 2002 National Policy and Strategic Framework document, with an appropriate revision as well as the recommendation to come to implementation of a quality system and management, remain valid and should be given high if not top priority by the Government(s) and the MoH in particular.
URGENT, THOUGH WELL PLANNED AND PREPARED, ACTION IS NEEDED.
Such action should follow the principles of improvement management (Deming cycle) – Plan, Implement, Monitor and Adjust where appropriate.
RECOMMENDATIONS
Given the minimal progress made over the past decade years and the extreme urgency of the situation of the blood supply and transfusion practices in Pakistan, as well as the outcome of the formal meetings with the Ministry of Health and other stakeholders,
Given the 2002 ‘National Blood Policy and Strategic Framework 2003-2007 for Blood Transfusion Services in Pakistan’,
it is strongly recommended that:
Top priorities
- the National and Provincial Ministries of Health should be urged to amend, accept and endorse the necessary legislation and regulation[6] that will guarantee the implementation of a nationally supported safe, efficacious, affordable and sustainable blood supply system and allow equity in access to and affordability of safe blood;
- the Pakistan National and Provincial Governments should be urged to allocate appropriate and adequate budget for the implementation of a safe, efficacious, affordable and sustainable blood supply system, at least for the next biennium to secure progress of implementation;
- the Provinces and their Districts should be urged to fully support the policy and strategies of the Blood Safety Reform programme in order to harmonise the Health Sector in the necessary reform;
- the National co-ordinator of the Blood Safety Reform programme should be given clear terms of reference (authority) to allow adequate and progressive action to be taken;
and
- the existing NBTC should be activated through clear terms of reference and related authority, and supported with appropriate material for structuring and organising the suggested structure according to current WHO recommendations and GMP principles, including the concept of quality management
- the Blood Safety Reform project should be monitored and evaluated carefully and at regular intervals (at least every 6 month during the initiation, transition and consolidation phase);
- donor organisations such as USAID, The World Bank and others should be identified and approached to support the necessary capital investment based on facilities and simple robust and functional equipment for the Provincial and District Establishments/ Blood Centres over the transition and consolidation period;
- further education and training of provincial and district leadership (key people), facilitated through WHO and donor organisations, in order to acquire the necessary knowledge, expertise and managerial skills. Such education and training should follow a ‘train the trainer’ principle and be given an evaluation and follow up;
- education and training of identified staff involved at all levels in Pakistan, making use of available education and training materials of i.e. WHO (Distance Learning Materials) and others (Universities and Colleges, WHO Collaborating Centres, etc.);
finally
The project be given a consultative follow-up to secure the necessary progress of implementation, keeping in mind the World Health Assembly resolutions with respect to blood donation and blood transfusion.
PLAN OF ACTION
IMMEDIATE (initiation) -
· Implement the Laws (Ordinances) regulating blood transfusion,
while simultaneously
· Initiate amendments to these ‘ordinances’ to incorporate the ethical principles
of blood donation and transfusion[7].
To be completed by the end of 2005
National Blood Transfusion Committee (NBTC)
Terms of reference:
1. to set the policies and define the strategies (including a budget plan);
2. to organise the structural framework for a National/Provincial blood supply system, vein to vein.
The NBTC should consist of experts from various sites of the country and with specific expertise, organisation and management skills:
1. Management and Organisation expert: General structure and organisation, policies and strategies, legal and regulatory issues based on international principles (WHO, IRCC, ISBT, EU, CoE and others)[8];
2. Financial Management expert: Economical aspects, finances, supplier issues and equipment, facilities.
3. Community Mobilisation expert: Community involvement, public relations and donor management;
4. Management Development expert: Personnel, education and training, career structure;
5. Blood Bank Technology expert: Standards of practice, quality system and quality management;
6. Transfusion Medicine expert: Clinical interface, appropriate use of human blood, alternatives and haemovigilance;
The NBTC should be given adequate MoH authority, be responsible for implementation of the terms of reference and held accountable for the results within the given time frame (initiation, transition and consolidation).
The NBTC could be advised over the period of structuring, organisation and implementation (transition and consolidation) by an expert consultant (i.e. through WHO or a donor country).
Each NBTC member, where appropriate, should be offered training focused at the principles, organisation and management aspects of the respective field of attention.
Organisation of Task Forces –
Each NBTC member will chair a Task Force focused on each of the 8 defined Strategic Areas of attention. The Task Forces should be composed of experts selected from various parts of the country and various parties involved.
Time frame –
The NBTC and the related 8 Strategic Area Task Forces should be given a limited time frame (i.e. 2 year maximal) to complete their initial tasks.
Task Forces proposed could be clustered in
Cluster I – Organisation, structure and management
a. Managerial and governing structure
b. Legal and regulatory affairs
c. Financing, budget and insurance
Cluster II – Resources
d. Facilities and equipment
e. Personnel and education/training
f. Quality System and Quality Management
g. Data management and ICT
Cluster III – Core business (procurement)
h. Donor issues including the community interface
i. Processing and storage (optimal use)
j. Laboratory controls (mandatory TTI and ABO/RhD, in process)
k. Clinical interface and rational use; haemovigilance
l. Logistics – collection and supply
Cluster IV – Process improvement
m. Research and development
n. Capacity building – continuous education (competence and awareness)
MEDIUM TERM (transition and consolidation) –
Over the five years to come (including the 2 years NBTC and TF work) the change should take place by implementing the Blood Safety Reform project.
To be completed by the end of 2010
National Blood Safety Reform Project –
General considerations:
Given the more than urgent need to reform the current fragmented, inadequate, unsafe and inefficient blood supply in the country (all provinces), it is advisable to reform the structure in a Provincial and District set up, where Blood Establishments (District HQ Blood Units), independent from the Hospitals, are responsible for the procurement and adequate and sustainable supply of safe and efficacious blood components to the hospitals in the districts.
As producers and suppliers of quality blood components they are ‘product liable’ and therefore have to be independent from the customers.
The hospitals with their Hospital Blood Banks or Transfusion Services, are responsible for the rational and appropriate clinical use of the blood components supplied (patient care).
There are a substantial number of high risk public and private (hospital) blood banks/blood units, that needs to be faced out without further delay (political decision). However, this can only be done when alternatives to guarantee patient care have been created. Through the upgrading of the identified district centres the existing high risk hospital blood banks/blood units should be faced out without further delay. This might need political courage and wisdom.
The current highly unreliable and unsafe donor ‘system’ needs an urgent attention and reform. Donation through (family) replacement and ‘blood sellers’ as well as forcing donors/family to pay for the testing and often also the blood bags should be faced out with high priority.
To create a reliable safe voluntary and non-remunerated blood donor system in compliance with the principles and recommendations of WHO, IRCC, ISBT Code of Ethics, EU Directive 2002/98 and CoE, the MoHs are urged to recognise their responsibility for allocation and provision of adequate budget for blood safety and in particular for the mandatory ‘State of the Art’ infectious disease marker testing marker and confirmation.
The change will demand full commitment and support from the National and Provincial Ministries of Health, the community by and large, the medical profession (existing blood banks, hospitals and clinicians) and the media and education institutions.
Training and education of appropriate staff at all levels should be started immediately and evaluated. This includes donor management, technical, medical, managerial and quality management training.
So, appropriate curricula and training facilities have to be developed as soon as possible
REPORT OF ACTIVITIES –
Sunday 06 February 2005
Travel by air from Groningen, NL to Islamabad, PK.
Monday 07 February 2005
Arrival in Islamabad at 04.40 am.
Afternoon – meeting at the NACP office with Dr. Asma BOKARI, National Programme Manager, Dr. Muhammad TARIQ, FHI Programme Officer (Pakistan Country Office), Dr. Mazhar Kazi BIRJEES, Chief Public Health Laboratories Division NIH and Dr. Ayesha RASHEED, NACP Programme Officer.
Discussion on Terms of Reference, need for background information and field programme for the mission[9] including the set up and outline of the planned consultative workshop on Quality Assurance. The workshop should focus on the managerial leadership in transfusion medicine (both procurement and clinical use).
FHI Pakistan country office – meeting with Dr. Naseer Muhammad NIZAMANI, Country Director and Dr. Muhammad TARIQ. Discussion on the project and mission programme and FHI support. Dr. TARIQ will be the coordinator and accompanying person.