Abstract
Background
In the Netherlands, the first formal haemophilia comprehensive care centre was established in 1964, and Dutch haemophilia doctors have been organised since 1972. Although several steps were taken to centralise haemophilia care and maintain quality of care, treatment was still delivered in many hospitals, and formal criteria for haemophilia treatment centres as well as a national haemophilia registry were lacking.
Material and methods
In collaboration with patients and other stakeholders, Dutch haemophilia doctors have undertaken a formal process to draft new quality standards for the haemophilia treatment centres. First a project group including doctors, nurses, patients and the institute for harmonisation of quality standards undertook a literature study on quality standards and performed explorative visits to several haemophilia treatment centres in the Netherlands. Afterwards concept standards were defined and validated in two treatment centres. Next, the concept standards were evaluated by haemophilia doctors, patients, health insurance representatives and regulators. Finally, the final version of the standards of care was approved by Central body of Experts on quality standards in clinical care and the Dutch Ministry of Health.
Results
A team of expert auditors have been trained and, together with an independent auditor, will perform audits in haemophilia centres applying for formal certification. Concomitantly, a national registry for haemophilia and allied disorders is being set up.
Discussion
It is expected that these processes will lead to further concentration and improved quality of haemophilia care in the Netherlands.
Keywords: standards, quality, audit, registry, haemophilia
Introduction
Haemophilia in the Netherlands
The Netherlands is a densely populated country in Western Europe and has a population of 16.5 million inhabitants, who are living on an area of 33,883 Km2, with a population density of 487 per km2.
Although a formal haemophilia registry is still lacking, the estimated number of patients with haemophilia is 1,600 to 1,800, including around 800 with severe haemophilia (< 0.01 U/mL of coagulation factor [F]VIII/IX). Simon van Creveld (1894–1971), professor of paediatrics at the University of Amsterdam since 1938, was the Dutch pioneer regarding the organisation of haemophilia care.
Historical organisation of Dutch Haemophilia care
1950–1998
Haemophilia care has always been well organised in our country. Already in 1950, Simon van Creveld founded a specialized clinic for children with chronic diseases, including a specialised centre for children with haemophilia. In 1964, the first haemophilia clinic in the world was officially opened by the Dutch Queen Juliana. This haemophilia clinic was an example for many other clinics in the world, and was recognised by the World Federation of Haemophilia. In 1971, Professor van Creveld died and the clinic was named Van Creveldkliniek. In the late 1960s prophylactic replacement therapy was introduced1, followed by home treatment in 1974 and low dose immune tolerance in 19812. Meanwhile, treatment with cryoprecipitate infusions was applied in many hospitals in the Netherlands.
The Dutch Haemophilia Centres Doctors Organisation (NVHB) was established in 1972 and this organisation is still active. The doctors from the NVHB meet every three months. These meetings are also attended by a representative of the manufacturers of coagulation factor concentrates, the Haemophilia Patients Organisation (NVHP) and the haemophilia nurses. Clinical problems and management issues are discussed, as well as side effects of treatment.
In 1981 the Van Creveldkliniek was the national haemophilia treatment centre and eight hospitals were recognised as regional treatment centres, but 21 other hospitals also treated haemophilia patients. This situation remained till 1999, without any quality control. The number of patients treated in these hospitals centre varied from 8 to 600 patients, which resulted in a variability in expertise and quality of care.
1999–2002
In 1999, The Ministry of Health in collaboration with the doctors from the NVHB and the Dutch Haemophilia Patient Society (NVHP), wrote a haemophilia management policy stating that care for patients with haemophilia should be centralised in haemophilia treatment centres to ensure quality of care by concentrating expertise. No distinction was made between national and regional centres, nor between treatment centres and comprehensive care centres at that time. This resulted in 16 haemophilia treatment centres geographically distributed over the country, ensuring treatment in hospitals nearby for all patients, most of these centres treated adults only.
2002-today
In 2002 and 2003 the 1999-haemophilia management policy was evaluated and it turned out only 6/16 centres complied with the standards of care. It was advised to further centralise haemophilia care, but this advice was not followed due to opposition of the patient organisation, which was strongly in favour of treatment in hospitals nearby for all. Until 2013 still 13 hospitals were treating haemophilia patients, with patient numbers ranging from under 20 to over 500 per centre. A consensus treatment guideline was drafted by doctors of the NVHB and published in 20093.
Complications of haemophilia and of treatment have been registered every three months in a national system (KWARK) since 2002. In addition three treatment centres report their complications to the European Haemophilia Safety Surveillance (EUHASS) database, www.EUHASS.org.
Material and methods
New quality system for haemophilia in the Netherlands
Life-long treatment of haemophilia includes many medical disciplines and requires experience and coordination for optimum results. It has been established that centralised haemophilia care improves patient outcome in different settings4–6. Although the European principles of haemophilia care were formally established in 20087, adherence to these principles is not yet perfect8. In 2009 the NVHB took the initiative to start for a new quality system for haemophilia care in the Netherlands. With financial support of the Ministry of Health a formal development process was undertaken from 2009 to 2011. First, a project group consisting of doctors from larger and smaller haemophilia treatment centres, nurses, and patient representatives in collaboration with the institute for harmonisation of quality standards in clinical care (Stichting HKZ) undertook a study of available literature on quality standards and performed explorative visits to two Dutch haemophilia treatment centres. Secondly, concept standards were defined, which were validated in two treatment centres to test their use in clinical practice. Next, the concept standards were evaluated by haemophilia doctors (NVHB), patients, health insurance representatives and regulators. Finally, the final version of the standards of care was approved by Central body of Experts on quality standards in clinical care (CCvD-Z/W) and submitted to the regulatory body at the Dutch Ministry of Health. Approval was obtained in March 2013.
Results
Standards for delivery of haemophilia care
The most important quality standards for delivery of haemophilia care are shown in Table I. These quality standards are considered mandatory for certification as a haemophilia treatment centre. Each centre should at least treat 40 patients with severe haemophilia, of which at least ten children. This quality norm has been implemented because we felt that in centres with fewer patients expertise cannot be guaranteed, not only by the haemophilia doctors and nurses, but also of other members of the multidisciplinary team involved. One of the new regulations was that a treatment centre should treat both children and adults. This will lead to a better transition of care from the children’s hospital to adult care. Also this will result in optimal genetic counselling and care for pregnant carriers of haemophilia and women with other bleeding disorders can be achieved during pregnancy and at delivery. In the team an internist/haematologist, as well as a paediatrician/haematologist should be available. These haemophilia doctors are primarily responsible for the care of these patients with respect to treatment of bleeding and coordinate prophylaxis to prevent bleeding. In addition they coordinate care before and after surgical procedures or other interventions. The team also consists of at least one specialised haemophilia nurse. Nurses are responsible for infusion of coagulation factor concentrates as well as for instructing and teaching patients, both children and adults, how to infuse coagulation factor concentrates and supporting patients on home treatment. They also are involved in teaching other nurses in the hospital. In addition, every centre should have a multidisciplinary team including a physical therapist, orthopaedic surgeon, rehabilitation doctor, clinical genetic specialist and social worker or psychologist. There has to be direct collaboration with haepatologists or specialist in infectious diseases and with gynaecologists to take care of pregnant carriers of haemophilia or women with other bleeding disorders, including von Willebrand disease. There is a need for a dedicated dentist or surgeon for dental care in patients with bleeding disorders. The multidisciplinary team meets with minimum intervals (Table I). In addition every haemophilia treatment centre has dedicated laboratory facilities which offers measurements of coagulation factor analysis, including FVIII, FIX, von Willebrand factor and other individual coagulation factors at all hours. Routine molecular diagnostic analysis of mutations in FVIII or FIX is performed and centralised in four treatment centres. All centres have adequate supply of coagulation factor concentrates for all bleeding disorders available at all times.
Table I.
Most important quality standards for Haemophilia Treatment Centres in the Netherlands.
| Index | Crucial standards | Note |
|---|---|---|
| Number of patients with severe haemophilia | Minimum 40 of which at least 10 children | Including both children and adults |
| Multidisciplinary haemophilia team | Internist-haematologist for adults Paediatrician-haematologist for children Haemophilia nurse/specialised nurse Physical therapist Social worker/psychologist |
|
| Dedicated protocols for | Diagnostics Treatment of bleeding Prophylaxis Peri-operative period Emergency department Treatment in case of inhibitors Treatment of inhibitors Treatment and prevention of viral infections Methods of infusion of coagulation factors Guidance of haemophilia carriers Education for home treatment |
|
| Registration of patients in national registry | NA | |
| Complication registration | NA | |
| Regular meetings of different disciplines | Adult and paediatric haemophilia doctors | Every month |
| Orthopaedic surgeons/physical therapists and rehabilitation experts | Every 2 months | |
| Haemophilia expert available for 24 hours a day 7 days a week | NA | |
| Every patient has an individual treatment plan | NA | |
| For every bleeding disorder adequate supply of coagulation factor concentrate available | NA |
NA: not applicable.
Patients with haemophilia and allied bleeding disorders who are treated with coagulation factor concentrates are seen at least once a year in the haemophilia treatment centre. Patients with severe haemophilia are seen more often, at least 2 to 4 times a year. Surgery should always be performed in one of the haemophilia treatment centres. For every patient an individual treatment plan is made and available in the electronic patient files. In this treatment plan, the diagnosis, treatment in case of acute bleeding or surgery, and co-morbidity are specified. Carriers of haemophilia, especially women with reduced FVIII of FIX (<40%), should be registered in one of the Haemophilia Treatment Centres (HTCs) in order to receive adequate treatment for bleeding, pregnancies and delivery, and obtain genetic counseling.
Certification and auditing of Treatment Centres
After approval of the regulations in March 2013, candidate treatment centres have to apply for certification as a Haemophilia Treatment Centre (HTC). This includes a 1–2 day audit of each candidate centre. For this purpose a limited number of haemophilia doctors and nurses received training to act as haemophilia experts-auditors. Centres will be visited by a team of a doctor, a nurse and one auditor of an official specialised auditing company (Det Norske Veritas, Barendrecht, the Netherlands).
The certificate will be evaluated yearly and audits will be performed every three years. Based on the new standards that have been set up, four HTCs have decided to stop their function as haemophilia treatment centre and two centres have been founded by merging four former HTCs. Other centres who were previously separated into a paediatric and adult centre in the same city are intensifying collaboration to provide more continuity of care and operate as a single centre. Currently, there are in seven candidate HTCs in the Netherlands: Haemophilia Treatment Centre south-west Netherlands (Leiden University Medical Centre, Leiden & HAGA Hospital, The Hague), Haemophilia Treatment Centre south (Maxima Medical Centre Eindhoven & Maastricht University Medical Centre), Academic Medical Centre Amsterdam, University Medical Centre Groningen, Radboud University Medical Centre Nijmegen, University Medical Centre Utrecht (van Creveldkliniek), and Erasmus University Medical Centre Rotterdam. The further centralisation of haemophilia care will lead to larger travel distances for patients, but considering the presumed benefit and the relatively small distances in the Netherlands the patients organisation have decided that quality is more important that proximity.
Registration of patients and coagulation factor concentrates
Although the Netherlands has a registry of blood products transfused since April 1999 and a registry of mortality, viral infections, and side effects of haemophilia treatment since 2002 (KWARK), there is no formal registry of Dutch haemophilia patients. Despite this, participation in a national haemophilia registry is part of the principles of haemophilia care7 and the Dutch quality regulations. At the same time of starting the certification process, additional funding from The Dutch Organisation for Health Research and Development (ZONMW) was obtained to initiate a registry of Dutch patients with haemophilia and allied bleeding disorders.
The registry will use a web-based platform, starting with a database of all patients with their diagnosis, and links to electronic diaries and hospital databases in the second phase of development. The aim of this registry is to provide exact data on the number of patients according to diagnosis, the use of various clotting factor concentrates, safety data and data on outcomes. The registry will serve several purposes. For evaluating treatment and side effects, data across treatment centres can be compared. For decision makers, the registry will provide an overview of the total number of patients according to diagnosis, including data on clotting factor consumption. For research, the registry will serve as a base for the haemophilia in the Netherlands (Haemophilia HIN) projects9. It will identify nationwide sub cohorts (e.g. ex-inhibitor patients, or HIV infected patients) eligible for specific studies. Outcome data can be compared with other full cohorts (e.g. with data collected by United Kingdom Haemophilia Centre Doctors’ Organisation in the United Kingdom). Data on side effects can be used for post-marketing surveillance of new clotting factors, which will be registered from 2014 onwards. In addition, data on side effects are entered in EUHASS (European Haemophilia Safety Surveillance System) and used in comparison with those from other countries.
Reimbursement
In the Netherlands, health insurance is mandatory and up to 2012 all costs for clotting factor concentrates were covered without restriction. Since 2012, hospital budgets, including budget for clotting factor concentrates, are fixed at the level of 2010, with a maximum annual growth of 2.5%. As consumption shows a yearly increase of around 5 %, these budgets are insufficient. Individual centers have negotiated with health insurance companies to increase the budget and at the same time with manufacturers of coagulation factor concentrates to reduce the price of concentrates, e.g. by using only one FVIII product. It is expected that future reimbursement of haemophilia care will be conditional on certification of the HTCs.
Conclusion
In an effort to improve the quality of haemophilia care in the Netherlands the NVHB, in collaboration with patients and other stakeholders, have undertaken a formal process to draft new quality standards for the HTCs. The quality standards were approved by the regulatory agencies and will be enforced by a formal auditing process initiated in 2014. Concomitantly, a national registry for haemophilia and allied disorders is being set up. It is expected that these processes will lead to further centralisation and improved quality of haemophilia care in the Netherlands.
Footnotes
The Authors declare no conflicts of interest.
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