The safety of blood and blood products has been a highly debated issue as far as public health is concerned, and has always been the focus of attention for both the public and the media. Why do you think this is?
The safety of blood and blood products is the real focus of attention for the public and the media, as one of the most ‘sensitive’ matters in medical science. This is largely due to the intense emotional reaction associated with cultural, religious and metaphysical preconceptions about the ‘red liquid tissue’ that flows in our veins. Back in ancient times, the dual power of blood was highlighted by Euripides in the scene where Athena gave Asclepius, the god of medicine, two drops of Medusa the Gorgon’s blood: one drop would treat all diseases and preserve life, while the other was lethal.
Scientific discoveries in immunohematology in the 20th century established blood transfusion as part of the treatment for a variety of diseases and opened the way for surgical and other operations on millions of people every year, thereby responding to the issue of blood safety and also dispelling the contradictory images of blood as a carrier of life and suffering at the same time.
What was the status of blood donation and safety 20-30 years ago and what is it today? Have we actually made significant progress?
As regards the microbiological and virological safety of blood, up until 1980 blood was screened for syphilis and hepatitis B, and the review of the potential donor’s medical history formed the basis for the selection of donors.
It was the emergence of acquired immune deficiency syndrome (AIDS) in the early 1980s that upset established practices regarding blood transfusions and undermined the confidence of the public, patients and the medical community in the safety of transfusion of blood components.
From then on, the focus of attention turned to blood safety, with the aim of minimizing the risks of transfusion and preventing the transmission of infectious diseases through blood. There was a worldwide effort to protect blood transfusions by establishing appropriate health policies and institutionalizing blood safety measures.
As far as Europe is concerned, blood safety is the subject of the European Union (EU)’s first law (Directive) in an effort to implement Article 152 on public health of the Treaty of Amsterdam. At the same time, the Council of Europe and the World Health Organization (WHO) have established standards and principles for every procedure within donor selection and blood collection, processing, testing, storage and distribution, taking into account the scientific advances and the epidemiological data for each country.
To achieve blood safety, the first and foremost condition is the consensus of a competent government and the establishment of the appropriate organizational and legislative framework for blood donation in each country.
Dr Politis, you are the most competent person to tell us whether we have succeeded as a country and as a health system in this particular domain. Are we considered to be one of the successful countries today?
Yes, we have been successful for the following reasons.
- We have had no remunerated blood donation since March 1979.
- Greece was among the first countries in Europe to enact Law 1820 on Blood Transfusion in 1988, based on the recommendations of the Council of Europe and WHO, and later Law 3402/2005 in line with the European Directive 2002/98/EC.
- The legal toolkit in blood transfusion comprises a multitude of presidential decrees, ministerial decisions and circulars that, based on the recommendations of the Blood Transfusion Committee, provide guidelines for the scientific and organizational framework of blood donation and transfusion.
- The National Blood Center was established in 2005 and is gradually becoming a blood supervisory and control authority.
- We have increased blood collection considerably and we have institutionalized all regulations on blood safety and quality, in line with the European Directives 2004/33, 2005/ 61 and 2005/62.
- The ongoing collaboration between our services and the volunteer donors’ associations and groups has contributed decisively to the development of voluntary blood donation.
- Together with France and the United Kingdom, our country has established a system of hemovigilance overseen by the Co-ordinating Hemovigilance Center (SKAE), which functions as a department of the Hellenic Center for Disease Control and Prevention (HCDCP).
- We have made significant advancements in immunohematology, in the serological testing of blood and the molecular control of blood-transmitted infections using nucleic acid technology (NAT). In this way, the safety of blood has improved considerably.
- We have contributed to a rationalized use of blood and blood components.
- Blood donation has contributed decisively to improving the ‘picture’ of patients with thalassemia and the treatment of people with hemophilia and other bleeding disorders.
- We have introduced methods of leukapheresis, irradiation and pathogen inactivation in plasma, and we have also increased the collection of platelets with automated aphaeresis procedures.
- There have been several more achievements for blood donation in Greece, the most important of which is the creation of a sense of family for all blood transfusion services, which have common objectives and apply common technical practices.
- There are several shortcomings, however, and much remains to be done in restructuring our blood system in order to achieve a more efficient blood supply and better blood-donor management, and to increase quality assurance for our services. The nationwide implementation of computerized systems and the operation of our services within a centralized scheme will accelerate progress in blood safety and quality, and it will also save resources that could be reallocated to improving public education and information to promote further regular voluntary blood donation. It is also necessary for all blood services to obtain a quality certificate and to improve the overall performance of transfusion according to the requirements of the inspections.
- The development of a valid national plasma fractionation program for the production of albumin and immunoglobulins remains to be accomplished, while much of the collected plasma is overtransfused.
Let us now focus on vector-borne diseases. Has the emergence of West Nile virus (WNV) infections in 2010 as well as the resurgence (at a local level) of malaria in 2011 complicated matters for blood banks, and to what extent? What problems have they caused?
Safety measures had to be taken against WNV infections in affected areas in 2010 and against malaria in the region of Eurotas in Laconia and several areas in Attica. These measures affected the blood supply adversely during the summer months, when there is usually a decrease in blood collection at the same time as the demand for blood increases because of increased traveling and tourism resulting in a greater number of accidents and other emergencies. In particular, the donor deferral measures and the cancellation of blood sessions caused dysfunction in major hospitals in Attica, where a large supply of blood is necessary to accommodate surgical, orthopedic and other operations, as well as to treat multi-transfused, oncology and other patients. The implementation of NAT blood screening for WNV provided significant support for the blood transfusion services and allowed sufficiency as well as safety of the blood supply.
We must stress the significant efforts made by the National Blood Center and the donors’ associations with regard to the effective management of the blood supply at a national level and the transportation of blood to the areas particularly affected by the WNV epidemic and the resurgence of malaria. We should also mention the efforts and collaboration between the National Blood Center and the Co-ordinating Hemovigilance Center with public health professionals, HCDCP services and scientists of other specialties to determine the affected areas in accordance with the recommendations of the European Centre for Disease Prevention and Control.
Let us now move on to our own matters. What role does the HCCH/HCDCP play in blood safety and hemovigilance? Give us a brief outline of its activities and their significance.
In our country, the relevant authority for hemovigilance is SKAE, which was founded by the Hellenic Center for Infectious Diseases Control (Board decision, during the 23rd meeting 1995, OG 831/29 June 2001 – Internal Regulation CCID) and institutionalized as the agency that is responsible for hemovigilance in our country by virtue of OG 261/17-02-2011. Since January 2008, SKAE has been located in HCDCP’s headquarters and has operated using personnel qualified in medical issues such as transfusion, public health, laboratory blood screening, counselling, statistical analysis, training and organization. It was established in line with European efforts to implement quality and safety standards in blood donation and transfusion, and particularly to limit the risks that arise in this area of public health, thus improving the safety of the blood transfusion chain from donor to patient. To achieve this, we have developed a reliable epidemiological surveillance system for adverse reactions and events associated with blood donation and transfusion at local (hospital), regional (six locations) and national (SKAE) levels.
This is a support mechanism for blood transfusion and public health using the infrastructure of HCDCP and the Ministry of Health. SKAE notifies the results of epidemiological surveillance to HCDCP and the National Blood Center. The Greek efforts in hemovigilance are based on voluntary participation, confidentiality and protection of personal data, education and an ongoing dialogue between the blood services and clinical departments as well as all stakeholders in blood donation and transfusion therapy. SKAE is a founding member of the European (and now International) Hemovigilance Network, and co-ordinates and administers the international surveillance database for adverse reactions associated with transfusion and donation (International Surveillance of Transfusion Associated Reactions; ISTARE).
SKAE has worked systematically to present the epidemiological situation of blood-transmitted infections and has recommended corrective and preventive measures in order to improve blood safety. In particular, it has highlighted the value of analysis of chronological trends in the prevalence of infections depending on the frequency of blood donation and the quality indicators of the blood services. Hemovigilance for all unforeseen and adverse reactions and events associated with transfusion has led to recommendations for the assignment of a unique code to each patient admitted to a hospital and its use for patient identification in all medical procedures and blood transfusion. Moreover, SKAE recommends that a blood order form be completed and the patient’s details be confirmed prior to transfusion at the clinic, as well as the use of computerized methods to prevent errors, both those leading to events (an incidence rate of 1:8,787 blood components) and to ‘near miss’ events (1:2,114). According to data collected by SKAE, human errors and failure of equipment account for 39% and 20%, respectively, of adverse events.
Although this question is considered to be a routine one, please tell us how difficult it is (if it is) to maintain high levels of blood safety in a period of economic crisis? Have the general budget cuts in the public sector threatened or are they still threatening this sensitive domain of public health?
Yes, the safety of blood has occasionally been threatened by shortages in reagents and consumables. Also, a reduced number of staff in the blood services for various reasons (voluntary retirement, early retirement, suspension, minimum recruitment, etc.), and a general feeling of insecurity about the future have sometimes had a negative effect on the efficiency of blood donation and transfusion. Concessions on matters of quality have sometimes been made, while blood centers have occasionally felt that the management is not as supportive as it should be.
In these difficult times, what has saved the day is the solidarity among blood centers and the assistance of blood donors and the National Blood Center. Above all, the driving force has been the care for the patient who needs blood.
Would you please allow us a personal question? With all the distinctions you have achieved, both in Greece and abroad, during your long career, what have you remembered most vividly?
- Participation in the struggle for multi-transfused patients with thalassemia, who are trying to survive and to improve their health and their quality of life in collaboration with health professionals in treatment units and blood centers.
- The long battle for the recruitment of blood donors. The recognition of my contribution in this domain by the associations of voluntary blood donors and my appointment as chairperson of the Organizing and Scientific Committee of the 14th Amphictyony in Zappeion in 2000 were a great honor and valuable experience.
- The shock of AIDS in relation to blood safety.
- My first time as a national representative for blood at the Council of Europe and the feeling that my name was directly linked with my country.
- The 1995 meeting in Strasbourg for the provision of scientific and technical assistance to eastern and central European countries to restructure the blood donation system in those countries in order to ensure blood supply and safety. My appointment as head of the task force was a great responsibility for me.
- The emotions felt by my colleagues and my husband when I received an award from the International Hemovigilance Network (IHN) in Brussels for my contribution to the work of blood safety nationally and internationally.
Edited by Philip Koukouritakis