AHCDC clinical PRACTICE guidelines

REPORT ON A CONFERENCE:

STANDARDS FOR COMPREHENSIVE CARE OF HEMOPHILIA IN CANADA

WINNIPEG, MANITOBA, APRIL 30-MAY 1, 1998

Abstract: "KEY MESSAGES" OF the 1998 CONSENSUS CONFERENCE

Standards of Care

  • Hemophilia Comprehensive Care should be delivered according to a set of national standards which are uniform, but are sufficiently flexible to adapt to local needs.

  • National standards of care for hemophilia must be promulgated by a multidisciplinary Standards of Care Working Group, and they must be updated at regular intervals.

Hemophilia Comprehensive Care Programs

  • Hemophilia Comprehensive Care Programs should be officially designated as such by provincial Ministries of Health.

  • All Programs must offer core services, which may in some cases be provided by arrangement with other health care institutions. Some specialized services will be provided only by selected Programs, and made available to other Programs as needed.

Accountability

  • In order to maintain their accredition, designated Programs must be periodically reviewed by multidisciplinary review teams for their adherence to national standards.

  • Designated Programs must be accountable for all clotting factor concentrates and surrogates distributed within the area of their jurisdiction, using the CHARMS data base among other tools.

Funding Models

  • Designated Programs should be supported by provincial MOH, but there is room for flexibility and diversity in funding models for their operational costs.

  • Responsibility for funding of clotting factor concentrates and their surrogates should remain centralized.

 

Table of Contents

SECTION 1. BACKGROUND TO THE CONFERENCE

 

 

1.0 Introduction

On April 30-May 1 1998, a consensus Conference on Standards for Comprehensive Care of Hemophilia in Canada was held in Winnipeg, under the the joint sponsorship of the Association of Hemophilia Clinic Directors of Canada (AHCDC) and the Canadian Hemophilia Society (CHS). These two organizations are the voices of the treaters and consumers respectively, and have a long history of effective teamwork. This Conference was timely in that it took place just as the structures of the Canadian Blood Services and of Héma-Québec were being announced. With these two new agencies about to assume control of the blood system, the AHCDC and the CHS resolved to assist them by proposing formal mechanisms for the integration of hemophilia care into the new enterprise. The city of Winnipeg was chosen as the site in order to emphasize the connection between this Conference and the one held in the same city exactly 20 years earlier, at the dawn of the era of hemophilia comprehensive care in Canada. The two Conferences were thus given the colloquial designations "Winnipeg I" and "Winnipeg II".

 

1.1 The current status of hemophilia care in Canada

Hemophilia programs are located in 20 cities across Canada. Programs were in most cases self-defined and self-designated, but they have achieved variable degrees of recognition within the hospital, university, and/or province in which they are located. They benefit from the support of the local Chapters and Regions of the CHS, and from the formal involvement of the professional program members in hemophilia-related associations. The most essential professional members of a Hemophilia Program are a nurse-coordinator and a medical director, who is a physician with expertise in the field of coagulation disorders. The Programs provide health services consistent with the comprehensive care model which was envisioned at the Winnipeg I conference in 1978. The settings for the Programs are quite heterogeneous. Depending on their institutional affiliation, Programs may enrol children, adults, or both. Some Programs are located in university medical centres, others in community hospitals. Some provide care for only a few dozen patients, others for several hundred. The clientele, which consists of people with hemophilia and a variety of related congenital coagulation disorders, develop their association with the Program through different routes. The Canadian Hemophilia Society (CHS) and its chapters and regions encourage their members to avail themselves of the benefits of centre-based comprehensive care, and in some cases they have provided material support for the establishment and/or operation of Programs. As the profile of a Program grows, self-referral by affected individuals and referral by local physicians become increasingly common. The benefits of Program-based comprehensive care can be gauged by the fact that most people with hemophilia in Canada, and almost all severely affected individuals, have established an association with one of the Comprehensive Care Programs.

 

The CHS is a well established organization, but the AHCDC has a much more recent history. The small number of Hemophilia Programs and medical directors facilitated the establishment of this collegial organization devoted to the medical, research, and programmatic aspects of hemophilia care in Canada. In the 5 years since its incorporation, the AHCDC established close linkages with the previous blood system. The AHCDC has worked in consultation with the CBA in planning the inclusion of some coagulation factor products in the treatment inventory, and has assisted the Agency in reviewing products prior to their introduction, performing outcome evaluation studies, compiling product utilization data, and assessing requests for the use of costly products available through the Emergency Drug Release Program. Along with the CHS, the AHCDC has also assisted the regulatory authorities and the distributor in conducting product advisories and withdrawals. The AHCDC maintains a close and effective working relationship with the CHS, largely through its structural linkages with the CHS Medical and Scientific Advisory Committee.

 

In the 20 years which have elapsed since the "Winnipeg I" Conference, a functional, efficient, and accountable system of hemophilia care has been developed in Canada. These accomplishments were made in the absence of official mandates or secure funding for Comprehensive Hemophilia Programs, and are thus eloquent testimony to the goodwill and constructive collaboration among consumers, providers, funders, and regulators. The fruits of the collaborations among the CHS, its Medical and Scientific Advisory Committee, the AHCDC, the associations of hemophilia nurse-coordinators, social workers, and physiotherapists (working under the auspices of the CHS) along with the Canadian Blood Agency and the Canadian Red Cross Society, include the following landmark accomplishments in hemophilia care in Canada: Excellent care provided through a nation-wide network of Hemophilia Programs

Development of an exceptionally well informed and sophisticated consumer community

Provision of reliable product utilization data through clinics, soon to be dramatically expedited by the CHARMS information management system

Surveillance studies around newly introduced products

Voluntary utilization guidelines

Expert input into the formulary of products offered through the blood system

Assistance in monitoring and approving the use of selected products

Assistance in conducting product recalls and advisories

A dramatic expansion of collaborative clinical research in hemophilia in Canada

 

 

1.2 Rationale for the "Winnipeg II" Conference on Standards for Comprehensive Care of Hemophilia

The integrity of the network of Hemophilia Comprehensive Care Programs described above cannot be taken for granted. Through frequent meetings and collaborative initiatives, the team members of CanadaÒs comprehensive Hemophilia Programs and their consumer partners have striven to maintain a uniform high quality of care across the nation. However, a Hemophilia Program can provide excellent comprehensive care only if the Ministry of Health in its province provides adequate resources, and its host hospital is committed to providing this service. Hemophilia care is currently funded through a patchwork of arrangements which differ from province to province. In times of contraction of health care resources, the lack of mandatory standards of care could result in the erosion of the level of service provided by some Hemophilia Programs. This would deprive some consumers of the benefits of expert comprehensive care, and would also jeopardize the ability of Hemophilia Programs to work as a national group to provide (and be held accountable for) product utilization data, review new products, perform outcome evaluation studies, and assist in product recalls and advisories.

 

We do not suggest that Hemophilia Programs should be exempt from the responsibility to justify their demand for public resources. On the contrary, consensually accepted standards and guidelines will give them the opportunity to do so, by providing the benchmarks against which they can be judged, and the processes by which they can be formally reviewed. The call for national standards of hemophilia comprehensive care is not a ploy to extract more funding from a stressed health care system. In fact, the adoption of standards of care may not require an enhanced overall level of funding above that which is currently devoted to the management of hemophilia, when all spending both within and outside of existing programs is included (see Section 3.2). In any event, the cost of the infrastructure to deliver hemophilia products is so minor in comparison to the cost of the products themselves that upgrading programs would have a negligible impact on the overall expenditures. The undeniable facts are that the treatment of hemophilia is expensive, the large majority of these expenses are accounted for by the cost of factor concentrates, and the price will be paid from the public purse. We have a vested interest in seeing that these costs are expended through an accountable network of Programs adhering to national standards, rather than through individual practitioners who may be non-expert, and who are unable to provide the value added benefits described in the preceding paragraphs.

 

1.3 Goals and expected outcomes of the "Winnipeg II" Conference on Standards for Comprehensive Care of Hemophilia in Canada

The overall goal of the conference was enunciated as follows:

To produce the first iteration of a living document, which will be continuously reviewed and updated, and which will set out the principles for the establishment of interdisciplinary standards for the comprehensive care of people with hemophilia and related diseases in Canada.

 

These consensually approved standards of care will allow us to consolidate the gains made in Canada over the past 20 years, by formalizing roles within the system for the Hemophilia Programs, the AHCDC, allied health professional associations, and the CHS. In this way, the responsibilites and expectations of all parties can be clearly defined, and a framework will be put in place through which outcome assessment and evaluations can be performed. This will also provide a framework through which resources can be appropriately directed, to enable Hemophilia Programs to discharge their defined responsibilites.

 

The desired outcomes anticipated to arise from the work done at the conference were:

the establishment of uniform national standards for the level of service and expertise necessary for a program to be formally designated as a Comprehensive Hemophilia Program

a framework within which guidelines can be developed for the clinical care of hemophilia and related diseases

mechanisms through which the above noted standards and guidelines can be continuously reviewed and revised, and through which designated programs can be periodically reviewed

national standards for the utilization of all clotting factor replacement products issued in Canada for the treatment of people with hemophilia and related diseases

formal roles which will integrate the Hemophilia Programs and the associations representing the relevant medical professionals (the AHCDC and the hemophilia clinic nurse coordinators group) into the newly reorganized blood system

 

Several benefits are expected to accrue if these outcomes are realized, and standards of care for hemophilia are promulgated and adopted:

a formal network of approved Programs adhering to uniform standards will assure the continued provision of high quality hemophilia care where it exists, and will lead to improved hemophilia care where this is necessary

a structure will be devised through which accountability can be assured for the use of all expensive and potentially dangerous clotting factor concentrates

multidisciplinary hemophilia care, which is expensive and requires highly specialized expertise, can be rationalized by delivery through the national network of Comprehensive Hemophilia Programs

an ongoing forum will be established, in which consumers, providers, funders, and regulators will jointly participate in refining optimal hemophilia care in the face of medical advances and changing social and political environments

 

SECTION 2: ORGANIZATION OF THE "WINNIPEG II" CONFERENCE ON STANDARDS FOR COMPREHENSIVE CARE OF HEMOPHILIA IN CANADA

 

 

The Conference participants included most of the members of the AHCDC and of the Hemophilia Nurse Coordinators Group, broad representation from the CHS, social workers and physiotherapists from hemophilia programs, as well as representatives of the funder (the Canadian Blood Agency), the regulator (the Bureau of Biologicals and Radiopharmaceuticals), and of the pharmaceutical companies which provide products used to treat people with congenital coagulation disorders. The Conference was organized by an Organizing Committee comprised of AHCDC and CHS representatives, and was co-chaired by Jerry Teitel, Administrative Vice-President, AHCDC, and Durhane Wong-Rieger, President, CHS.

 

At an opening plenary session, context for the subsequent deliberations was provided by means of a historical perspective (Martin Inwood) and a consumer perspective (Pam Wilton). External vantage points were provided in addresses given by Dr. Christopher Ludlam, Chairman of the United Kingdom Hemophilia Clinic Directors Organization, and by Dr. Keith Hoots, Vice-Chairman of the Medical and Scientific Advisory Committee of the (US) National Hemophilia Foundation. An appreciation of the strategies used in these two countries was helpful in allowing the participants to consider these issues as they pertain to the Canadian context. Drs. Ludlam and Hoots participated in the subsequent stages of the Conference. A full listing of participants is appended (Appendix "A").

 

After the opening plenary session, participants were divided into issue-oriented groups, each containing a similar distribution of stakeholders, comprising consumers, health care providers, and health care administrators. Each issue-oriented group was assigned one of three complementary themes. In order to maintain numbers which will facilitate interactions, each group was further divided into three working groups. The working groups met individually, and addressed their assigned areas. Each group was facilitated by a member of the Conference Organizing Committee. The issues which each group was asked to address are shown below. This list was intended to serve only as a general guide to the discussion, and there was expected to be considerable overlap among the groups. The groups were encouraged to be as creative and eclectic as possible.

 

GROUP 1: Structural aspects of the delivery of hemophilia comprehensive care.

Working group A: Designation and definition of hemophilia centres, and their place in the new Canadian Blood System

How can Hemophilia Programs be integrated into the blood system without compromising the integrity of the system?

Definition, designation, accreditation and stratification (?) of hemophilia treatment centres.

What is the federal role in hemophilia comprehensive care?

Working group B: Provision of resources to hemophilia centres

"Official" designation and support of Hemophilia Programs. How can/should this be done: the CBS (national)? the MOHs (provincial)? the blood centres (regional)?

How can Hemophilia Programs be funded in a way which is acceptable to hospitals and MOHs, and yet assures them sufficient resources to maintain standards?

Working group C: The mandate of hemophilia centres

What should be the scope of "Hemophilia" Programs: disease-oriented (congenital hemophilia, VWD, acquired hemophilia, etc)? product-oriented? other?

Hemophilia services outside the authority of centres: is this desirable? necessary? tolerable? Can or should the CBS control this, and if so, how?

Can Hemophilia Programs provide full responsibility for hemophilia care and full accountability for treatment products without violating the rights of treaters and consumers?

 

GROUP 2: Functional aspects of the delivery of hemophilia comprehensive care.

Working group A: Establishing standards of care

What mechanisms should be used for establishing, reviewing, and revising standards of care in Hemophilia Programs for the various professions: medical, nursing, physiotherapy, social work, other and allied health care?

Standards for consumers: rights and responsibilities: registration in Hemophilia Programs, access, choice, diaries, etc.

Responsibilities of designated Programs: patient care, research, guidelines, education, data collection and analysis

Working group B: The external environment in which Hemophilia Programs operate

The relationship between Hemophilia Programs and the hospitals and universities in which they are located.

Functional relationships: communications and interactions among Hemophilia Programs and the CBS and HémaQuébec blood centres, the BBR, and the LCDC (including information management, eg. the CHARMS system).

Roles and responsibilites of professional groups and associations: AHCDC, the nursing group, social work & physiotherapy groups, etc.

Roles and responsibilities of the CHS.

Working group C: Performance evaluation and outcome assessment

Who should establish the criteria for reviewing and accrediting Hemophilia Programs?

What process should be used for carrying out reviews of Hemophilia Programs? How should reviews be carried out? What are the positive and negative consequences of the review process?

How should the standards of care themselves be periodically reviewed and revised?

 

At the closing plenary session, a delegate from each working group presented a summary of their deliberations and recommendations. Subsequently, the facilitators provided more detailed written summaries. The following section (Section 3) represents the edited collation of the notes made at the conference, the written summaries, and clarification provided by the members of the organizing committee. It constitutes the official summary report of the Conference.

 

SECTION 3. REPORT OF THE ORGANIZING COMMITTEE, "WINNIPEG II" CONFERENCE ON STANDARDS FOR COMPREHENSIVE CARE OF HEMOPHILIA

 

 

3.0 Definitions: Hemophilia Comprehensive Care and Comprehensive Care Programs

The definition of hemophilia comprehensive care as proposed in the proceedings of the "Winnipeg I" conference held in 1978 remains largely appropriate, but certain points require elaboration or emphasis. A revised definition of comprehensive hemophilia care is as follows:

 

HEMOPHILIA COMPREHENSIVE CARE is a health care delivery system in which individuals and families with hereditary and related acquired bleeding disorders (such as inhibitor autoantibodies to coagulation factors) receive regular preventive and therapeutic input from members of a team of specialists who represent the many medical and allied health disciplines relevant to the management of these complex disorders. This team supervises the provision of optimal active and prophylactic hemostatic therapy, regularly assesses patients for physical and psychosocial complications, and educates and counsels patients, their families, and society at large regarding bleeding disorders and their complications. Team members also share their expertise in disorders of blood coagulation by providing assistance as necessary to the administrators and regulators of the blood system. They also advance the scientific basis of the care of people with hemophilia and related diseases, through basic and clinical research.

 

HEMOPHILIA COMPREHENSIVE CARE PROGRAMS provide expertise for the management of a full range of congenital and selected acquired bleeding disorders in men, women, and children. In this sense, the designation hemophilia comprehensive care is misleadingly narrow. However, given the historical resonance of this term and its widespread and unambiguous recognition in both the professional and consumer communities, it is recommended that this name be retained. One often speaks of "hemophilia clinics", a designation which emphasizes the geographical localization of Programs within hospitals and universities. In fact, the clinic unit is merely the administrative centre of a Program which is a regional or provincial resource. Therefore the designation "Hemophilia Program" is preferred.

 

The viability of a Hemophilia Comprehensive Care Program depends on its ability to enrol a sufficient number of patients, and on the ability of the all the key team members to provide a sufficient time commitment to the program and to maintain high levels of professional competence. Furthermore, each Program must have ready access to the laboratory expertise necessary to diagnose and manage complex coagulation disorders. These considerations must be tempered by the recognition that owing to the unique geographical features of Canada, in some regions a Program may be necessary to serve the needs of a large but relatively lightly populated area. It is also recognized that there must be a minimum of one Program per province. All such Programs, regardless of their size, are vital parts of the health care system.

 

3.1 Key Principles for the Organization of Hemophilia Comprehensive Care

Hemophilia services must be delivered through a health care pyramid whose base comprises the Hemophilia Program and the consumer organization, and which builds upward through the host hospitals, regional health boards where these exist, provincial Ministries of Health, and the national and federal agencies which are involved as regulators and payers. The system must incorporate an ongoing economic analysis of the costs of caring for people with hemophilia and other congenital bleeding disorders, to determine which current and evolving therapies provide positive benefits to health and to quality of life. Among the "new realities" in health care which must be considered when building the system of hemophilia care in Canada are:

the increased availability of technology and of opportunities for sharing information

the increasing demand for shrinking health care resources

changing demands for services provided by comprehensive care Hemophilia Programs

the need to increasingly move care from the hospital/clinic to the home, work, and school environments

increasing consumer participation in decision making, with the concomitant requirement for consumer education, responsibility, and accountability

 

RECOMMENDATION 1: Hemophilia Comprehensive Care should be delivered in Canada according to a set of uniform national standards. Wherever possible, these standards should be needs-based, data-driven and supported by evidence of effectiveness. Generic national standards will be developed, but they will be implemented locally. Therefore the delivery system must be flexible and adaptable, with the emphasis being the delivery of a uniformly high quality of care.

 

3.2 Justification of Hemophilia Comprehensive Care

The rationale for governments to provide secure funding for the total costs of Hemophilia Comprehensive Care Programs (ie. in addition to the cost of clotting factor products) is the principle that a small investment in infrastructure provides the mechanism by which accountability can be assured for the far larger costs of factor concentrates. It is important to recognize that these expenses are already borne by the system, but in an ad hoc and essentially disorganized fashion which does not allow for clear accountability. Therefore, implementation of these recommendations may not require incremental expenditures above those which are currently devoted to this segment of the health care system.

 

Hemophilia Programs can be held accountable only for the resources which they are mandated to manage. Therefore, it follows that accountability can only be achieved if Hemophilia Programs are formally accredited as regional or provincial resources and funded at a level which allows them to fulfill their mandate. Such accreditation can in turn only be bestowed upon Programs which meet and comply with national standards of care for the comprehensive management of congenital coagulation disorders.

 

It is in the public interest that the health care system be able to track and provide full accountability for clotting factor concentrates, costly products for which there are few qualifed recipients and prescribers, and potentially dangerous adverse effects. Accountability will provide assurance that these resources are being used with optimal safety and efficacy, that emerging utilization trends can be appreciated to help plan future purchases, that the occurrence of adverse effects can be quickly flagged and the information disseminated, and that recalls and advisories can be carried out efficiently and effectively. Since the large majority of these products are prescribed through Hemophilia Programs, and since the Programs now have the capability of collecting and collating national utilization data on behalf of the blood system (by means of the CHARMS data base system) it is logical that all clotting factor concentrates be reported through Hemophilia Programs. Indeed, there is no practical alternative reporting mechanism which will achieve the desirable goal of tracking the use of all clotting factor concentrates prescribed in Canada.

 

Since most concentrate use will be known to Programs and already entered on the CHARMS data base, this requirment will affect only that small percentage of concentrate which is prescribed by other physicians at other facilities. This will have to be reported promptly and regularly to a designated Program within the province.

 

This requirement does not compel consumers to access care through a Hemophilia Program. The purpose is not to impose restrictions on patients, but to manage the resource. This requirement will compel those treaters who are not part of a Hemophilia Program to forward their utilization data to a designated program. The data will be entered on that programÒs CHARMS data base, from which it is transmitted to the AHCDC office in Toronto, collated, and forwarded to the CBS (currently the CBA).

 

RECOMMENDATION 2: Each designated Hemophilia Comprehensive Care Program should accept accountability for all clotting factor concentrates and surrogates distributed within the area of its jurisdiction, including any such product prescribed outside the program itself. Pooled anonymous utilization data will be collated by the AHCDC and made available to the operators of the blood system, to allow them to plan purchases, flag inconsistencies, outliers, and adverse events, and to conduct efficient recalls and advisories as necessary. To carry out this mandate, the programs must be provided with the necessary resources, including support to maintain the CHARMS data base.

 

3.3 Designation Of Hemophilia Comprehensive Care Programs

Historically, programs arose in response to needs as perceived either by medical practitioners or by the consumers themselves, through the CHS or its affiliates. This was a natural and a productive process. However, Programs must exist, and often compete, within a complex environment consisting of the hospitals and medical schools which host them. Their vigour and viability depends on their ability to attract funding within the envelopes conferred on public hospitals by the respective Ministries of Health. In this environment, it is essential that Hemophilia Comprehensive Care Programs receive official designation as such, so that they can compete on an equal footing with other programs for the limited available resources. In theory, the process of designation of Hemophilia Comprehensive Care Programs could involve several potential bodies. Programs could be designated nationally by the Canadian Blood Services, provincially by the respective ministries of health, regionally by regional health authorities where these exist, or locally by the host hospitals. As a basic principal, the designating body should also be the funding body, but this process must not compromise the introduction of truly national standards.

 

We do not anticipate the sudden appearance of new Hemophilia Programs seeking status, but we anticipate that all existing Programs will wish to be so designated. We advocate a process by which existing Programs would strive to meet standards of care outlined in the definition of a program. If such standards are met, the program will achieve formal designation and by inference, funding.

 

RECOMMENDATION 3: Hemophilia Comprehensive Care Programs should be officially designated and supported by provincial Ministries of Health. The federal regulator, the operators (the CBS and Héma-Québec) and the Canadian Hemophilia Society should acknowledge and recognize these official designations.

 

RECOMMENDATION 4: Designated Hemophilia Comprehensive Care Programs must be accredited in order to maintain operational support. Accreditation will be conferred as a result of a periodic review process. The criteria will include adherence to national standards of care, and provision of a defined range of services with an acceptable level of expertise.

 

3.4 Range of Services Provided by Hemophilia Programs

Canada is a large country with a relatively small and dispersed population. There are considerable regional differences in needs and in funding of health care services. Therefore, it is evident that one model of Hemophilia Program might not be optimal for all regions of the country.

 

One model would be to stratify Hemophilia Programs by means of a rigid hierarchy which explicitly outlines the expectations and obligations of various classes of Programs. As described above, we recommend a more flexible model, in which every program must provide certain core services, and only certain Programs would provide more specialized services. Programs should be discouraged from attempting to provide services in which they could not gain proficiency or which they could not provide economically. In this case, consumers connected with these Programs must have access to these specialized services, by explicit agreement with Programs which can provide those services. The system must match the expectations and level of expertise of each centre to the resources with which it is provided.

 

RECOMMENDATION 5: Standards of care must be uniform across the country, and must reflect the state of the art in hemophilia care. However, there must be flexibility in the manner in which the standards are implemented at the local level, since Programs will vary in the range of services which they can offer. To ensure that all specialized services are readily available to all those who need them, accredited Hemophilia Comprehensive Care Programs may need to enter into special arrangements with other health care institutions.

 

3.5 Components of Hemophilia Comprehensive Care

3.5 (a) Content

Certain core services must be offered for a Program to be recognized as a Comprehensive Care Program. These core services have been outlined in various documents, including the "Vision of Comprehensive Care" endorsed by the CHS in 1995 and the Ontario Hemophilia Program Directors GroupÒs "Proposal for Optimal Comprehensive Care" also dated 1995. While medical, nursing, and laboratory services are the most self-evident requirements, the role of physiotherapists and social workers to hemophilia comprehensive care is critical, and merits comment. Physiotherapy and social work services are so fundamental that they should be provided by individuals who are specifically assigned to the Hemophilia Program, even if the caseload of the Program does not require a full time position. The practice of including Hemophilia Programs in a regular rotation roster for physiotherapists or social workers is not acceptable.

 

With the introduction by the AHCDC of the CHARMS Management Information System, it must also be emphasized that participation in CHARMS is a core service of a Canadian hemophilia comprehensive care program. Information technology is crucial for the dissemination of information outward, and the collation of data inward, maintenance of competency and facilitation of accountability and responsibility. This trend will continue to progress, as for example, Programs begin to make use of bar code technology to track product use. This information system will provide credible product utilization and clinical care data, and allow the creation of a national non-nominal data base to support evidence-based decision making.

 

Finally, fulfilling the functions of education and outreach is also essential to any recognized program, so that community health care providers can provide appropriate rpimary care for people with bleeding disorders. These functions must be provided by all members of the comprehensive care team.

 

Beyond the provision of core services, there are additional "special or specialized services" that need not be provided by all Comprehensive Care Programs, provided that they are made available to them. These services include highly specialized laboratory testing, performance of complex elective surgery, genetic testing and counselling, hepatology, obstetrics and gynecology, and management of complex infectious disease.

 

RECOMMENDATION 6: Standards of hemophilia care should include core services which must be provided by all Programs, and specialized services which must be provided only by selected Programs, and made available to other Programs as needed.

 

3.5 (b) Process

Standards of care provide a guide to the knowledge, skills, judgment and attitudes that are needed to practice safely. They will describe the accountabilities and responsibilities of each professional member of the comprehensive care team. They define performance criteria against which professionals may be compared by consumers and peers.

 

Standards must be developed by a multi-disciplinary working group comprising treaters, regulators, and consumers, and must be updated regularly, not less than every five years. Each of the professions identified as core to hemophilia comprehensive care must be represented in the Standards of Care Working Group. Standards must be consumer-centred, and must accomodate regional variability. They must incorporate and build upon existing expertise in the system, and must also have sufficient flexibility to accomodate stratification of Programs. Standards must address patient care expertise and services, research, and education (professional and lay) as well as peer review. The processes by which standards for hemophilia care are developed must be transparent.

 

RECOMMENDATION 7: Comprehensive standards of care for hemophilia must be promulgated by a multidisciplinary Standards of Care Working Group, and they must be updated at regular intervals.

 

3.5 (c)Scope of Hemophilia Program Responsibilities

The detailed standards of care will be produced by the working group described above. To assist them in this process, the working group will refer to existing guidelines, in particular (but not exclusively) those which were published by the AHCDC and endorsed by the MSAC of the CHS (currently under revision) and the Professional Standards for Registered Nurses and Registered Practical Nurses in Ontario (College of Nurses, Toronto, Ontario, June 1996). Additional guidelines will need to be developed, for example in the management of pregnancy, delivery, and neonatal care for women and infants with bleeding disorders.

 

The standards must refer to all the activities which fall under the mandate of comprehensive Hemophilia Programs, recognizing as noted above that not all of these activities are core services which must be offered at all centres. The scope of the services provided by Hemophilia Programs includes the following:

 

Expert clinical and laboratory diagnosis of congenital and complex acquired bleeding disorders

Expert multidisciplinary management of people with these disorders

Skilled counselling for individuals and families with these disorders

Continuing education of patients and families, emphasizing self-treatment in the home, at work, and at school

Maintenance of confidential clinical records

Participation in the CHARMS information management system, to optimize patient care, communication, and accountability

Educational resources and outreach to local and regional care providers

Education for medical and other professional trainees

Participation in collaborative clinical research and surveillance initiatives

Participation in professional associations, and through these in the generation of guidelines

 

In order to provide these services, each Hemophilia Comprehensive Care Program must have the necessary human and material resources. The professionals who need to be available on-site or in easy proximity (depending on the size of the Program) include a physician with special competence in hemostasis and clinical bleeding disorders (usually a hematologist), nurse-coordinator, social worker, physiotherapist, occupational therapist, rheumatologist, orthopedic surgeon, dentist, infectious disease/retrovirologist, obstetrician/gynecologist, hepatologist, geneticist, pyschologist, psychiatrist, data manager. Laboratory expertise in coagulation testing and blood banking is a prerequisite. In addition to the usual hospital and ambulatory services, other services which may be of particular value include specialists in the field of pain management, vocational rehabilitation, and child life.

 

The major material resource which must be available to Hemophilia Programs is free access to prescribe and distribute appropriate clotting factor replacement products and their surrogates. Hospital budgeting constraints must not constitute a restriction to accessing these products. By comparison, the costs related to those professional personnel who are not remunerated on a fee-for-service basis are modest.

 

 

3.6 Accreditation and Review of Hemophilia Comprehensive Care Programs

Peer review of Hemophilia Programs has been successfully implemented in the United Kingdom. The process must not be a punitive one. The review team must include experts in the varied aspects of hemophilia care, as well as meaningful consumer representation. The purpose of the review is to determine compliance with standards, but the review team must not just catalog activities of the program, but must also assess quality. The results of the review process must be transmitted to an agency which is external to and independent from hemophilia care, and which will have the authority to confer or revoke formal accreditation. The results must also be shared with the Hemophilia Program, which will receive the benefit of an independent assessment of its strengths and weaknesses. The Program may also find the results to be valuable in highlighting its stature at the host hospital and university, or as evidence to support its request for enhanced resources to allow it to meet standards. A model for this process is the Canadian Council on Health Facilities Accreditation, which is responsible for accreditation of public hospitals in Canada.

 

Successful accreditation will lead to new or renewed designation, and to funding. Failure of accreditation will result in a program being placed on probation, allowing a period of time for correction of its deficiencies. Failure to correct these deficiencies by the time of a future accreditation could result in loss of designation and potentially loss of funding. We are confident that such a process will not jeopardize patient care, as we anticipate that the probationary period will in almost all instances allow appropriate action to take place to remedy the identified deficiencies.

 

RECOMMENDATION 8: Multidisciplinary review teams must be struck to assess Hemophilia Comprehensive Care Programs. The mandate of the review team is to either recommend accreditation, or to identify deficiencies which must be addressed before accreditation can be granted.

 

3.7 Integration of Hemophilia Programs within the Canadian blood systems

There are at least three linkages through which meaningful interactions can be established between the Hemophilia Programs and the blood systems. One such interaction is between the Association of Hemophilia Clinic Directors of Canada and the executive levels of the blood agencies, the CBS and Héma-Québec. It is essential that the existing funding arrangements between the AHCDC and the CBA should be continued by the CBS and Héma-Québec. The consumer aspect of Hemophilia Programs represented by the CHS should establish reciprocal ties to the blood centres, and through these conduits to the Vice-President of Operations or other appropriate individual at the executive level of the CBS and Héma-Québec.

 

The preceding model does not address the federal role in Hemophilia Comprehensive Care. As the regulator, the Federal Government must remain closely integrated in the enterprise of hemophilia care via the Bureau of Biologics and Radiopharmaceuticals, the Laboratory Centre for Disease Control, and the National Blood Safety Council. The Hemophilia Programs, through the AHCDC, the CHS, and many of their members, have established close working relationships with these agencies, and these relationships must be maintained and strengthened.

 

3.7 (a) Hemophilia Comprehensive Care and the CHS

Programs will continue to be intimately linked at professional levels through the AHCDC and the associations of the allied health care groups (nursing, physiotherapy, social work). The CHS and its chapters and regions provide an essential channel of communication between consumers and providers. Regular annual meetings, and formal linkages such as the reciprocal representation between the AHCDC Executive Committee and the CHS MSAC provide forums for collaborative research, education, and problem solving. Increasing use must be made of electronic linkages: email, teleconferencing, videoconferencing, chat lines, etc.

 

3.7 (b) Hemophilia Comprehensive Care and Professional Associations (AHCDC, Hemophilia Research Society, Nursing Group, Social Work Group, etc)

Members of the comprehensive care team must be strongly encouraged to remain (or become) active, contributing members of the associations appropriate to their respective professions. These groups have formal and informal links with the Programs, provide forums for sharing information and expertise, and promote inter-disciplinary networking. Their input will be invaluable in the development and revision of standards. They also provide the infrastructure through which collaborative research can be planned and carried out.

3.7 (c) Hemophilia Comprehensive Care and Hospitals/Health Centres

As noted above, funding of Hemophilia Programs must not be a cause for conflict with the hospital/health centre in which it is located. The possibility of conflict arises from the nature of hemophilia care, which services a numerically small but resource-intensive patient population. This principle underlies our recommendation for a non-portable funding envelope.

 

For their part, hospitals in which Programs are sited must be given the assurance that hemophilia care is delivered by accredited, reviewed Programs, and that most of the care provided through these Programs is ambulatory and is delivered in a manner which incorporates many of the positive features of "managed" care. These features include evidence-based care guidelines.

 

3.7 (d) Hemophilia Comprehensive Care and Universities

Many Hemophilia Programs are located in university teaching hospitals, and the medical directors and other medical members of these Programs have full-time university faculty appointments. These Programs and their staff have become the major resources for teaching of congenital coagulation disorders in particular, and of hemostasis in general, to students in medical and other professional and scientific faculties and to graduate physicians pursuing further training leading to specialty certification.

 

The positioning of these Programs within universities provides the opportunity for Hemophilia Programs to compete for research laboratory space and for peer-reviewed intra-mural and extra-mural funding. It has also fostered valuable collaborative linkages between investigators in the clinical and the basic sciences.

 

3.7 (e) Hemophilia Comprehensive Care and the Regulator

The professional associations noted above, especially the AHCDC, should be the point of contact between Hemophilia Programs and federal agencies such as the BBR, the LCDC, and the National Blood Safety Council (NBSC).

 

3.8 Provision of Resources to Hemophilia Centres

3.8 (a) Funding of Clotting Factor Concentrates

Hospital-based budgeting of blood services (of which hemophilia care is a small segment) was recommended by Justice Krever, and is under consideration by the CBS and Héma-Québec. The rationale is presumably the assumption that this funding model can best ensure both accountability for utilization of blood resources, and the optimally safe provision of these resources. However, the blood system is sufficiently heterogeneous that these assumptions must be tested sectorally, not globally. In this regard, the sector which provides care for hemophilia and related diseases is distinguished by these key characteristics:

 

This care is targeted towards a small number of recipients

The specialized expertise needed to provide this care is possessed by a small number of providers

Hemophilia care consumes a disproportionately large share of health care resources

The provision of care is highly localized to the network of comprehensive hemophilia centres

 

Devolution of the responsibility for purchasing clotting factor concentrates to the local (hospital) level would be a regressive step. It would not only divert resources to inefficiently replicated hospital-based regulatory apparatuses, but more importantly would result in erosion of the universal provision of excellent care across Canada, owing to the enormous and unpredictable financial pressures which accompany the delivery of hemophilia care. This pattern has already been played out in both the United Kingdom and the United States.

 

RECOMMENDATION 9: Responsibility for funding for clotting factor concentrates should remain centralized. Given the unpredictability of the clinical course of hemophilia and its complications, a model in which these costs were borne at the hospital level would have a chilling effect on the willingness of hospitals to host Hemophilia Comprehensive Care Programs. Furthermore, such a model would jeopardize the principles of universality, comprehensiveness, portability, and accessibility, which are enshrined in the Canada Health Act.

 

3.8 (b) Funding of other costs of hemophilia comprehensive care

Designated Hemophilia Programs will require dedicated, protected funding, but the optimal funding model for may vary across the country. The most protected form of budgeting will be to establish non-portable cost centres within the hospitals which house the Programs. This funding model supports the development of regional referral clinics for patients with unusually complex, highly specialized needs. Funding provided through the hospital global budget can be workable provided the hospital administration is committed to maintain program resources at a level sufficient to meet the national standards, adhere to guidelines, and respond to deficiencies noted in audits.

 

RECOMMENDATION 10: Hemophilia Comprehensive Care Program costs other than those for clotting factor concentrates are comparatively modest and predictable. Therefore there is room for flexibility and diversity in funding models for these services. Non-portable cost centres provide the greatest degree of protection, but hospitals which are strongly committed to hemophilia comprehensive care can fund this activity through their global budgets. In this case, the hospital must be prepared to provide resources sufficient to allow the Program to meet accreditation standards.

 

SUMMARY: LIST OF THE RECOMMENDATIONS OF THE CONFERENCE ON STANDARDS FOR COMPREHENSIVE CARE OF HEMOPHILIA IN CANADA

 

 

The following recommendations address both a structural framework and a functional model for an integrated system which will provide excellent, accountable hemophilia care through a network of dedicated programs across Canada.

 

RECOMMENDATION 1

Hemophilia Comprehensive Care should be delivered in Canada according to a set of uniform national standards. Wherever possible, these standards should be needs-based, data-driven and supported by evidence of effectiveness. Generic national standards will be developed, but they will be implemented locally. Therefore the system must be flexible and adaptable, with the emphasis being the delivery of a uniformly high quality of care.

 

RECOMMENDATION 2

Each designated Hemophilia Comprehensive Care Program should accept accountability for all clotting factor concentrates and surrogates distributed within the area of its jurisdiction, including any such product prescribed outside the program itself. Pooled anonymous utilization data will be collated by the AHCDC and made available to the operators of the blood system, to allow them to plan purchases, flag inconsistencies, outliers, and adverse events, and to conduct efficient recalls and advisories as necessary. To carry out this mandate, the Programs must be provided with the necessary resources, including support to maintain the CHARMS data base.

 

RECOMMENDATION 3

Hemophilia Comprehensive Care Programs should be officially designated and supported by provincial Ministries of Health. The federal regulator, the operators (the CBS and Héma-Québec) and the Canadian Hemophilia Society should acknowledge and recognize these official designations.

 

RECOMMENDATION 4

Designated Hemophilia Comprehensive Care Programs must be accredited in order to maintain operational support. Accreditation will be conferred as a result of a periodic review process. The criteria will include adherence to national standards of care, and provision of a defined range of services with an acceptable level of expertise.

 

RECOMMENDATION 5

Standards of care must be uniform across the country, and must reflect the state of the art in hemophilia care. However, there must be flexibility in the manner in which the standards are implemented at the local level, since Programs will vary in the range of services which they can offer. To ensure that all specialized services are readily available to all those who need them, accredited Hemophilia Comprehensive Care Programs may need to enter into special arrangements with other health care institutions.

 

RECOMMENDATION 6

Standards of hemophilia care should include core services which must be provided by all Programs, and specialized services which must be provided only by selected Programs, and made available to other Programs as needed.

 

RECOMMENDATION 7

Comprehensive standards of care for hemophilia must be promulgated by a multidisciplinary Standards of Care Working Group, and they must be updated at regular intervals.

 

RECOMMENDATION 8

Multidisciplinary review teams must be struck to assess Hemophilia Comprehensive Care Programs. The mandate of the review team is to either recommend accreditation, or to identify deficiencies which must be addressed before accreditation can be granted.

 

RECOMMENDATION 9

Responsibility for funding for clotting factor concentrates should remain centralized. Given the unpredictability of the clinical course of hemophilia and its complications, a model in which these costs were borne at the hospital level would have a chilling effect on the willingness of hospitals to host Hemophilia Comprehensive Care Programs. Furthermore, such a model would jeopardize the principles of universality, comprehensiveness, portability, and accessibility, which are enshrined in the Canada Health Act.

 

RECOMMENDATION 10

Hemophilia Comprehensive Care Program costs other than those for clotting factor concentrates are comparatively modest and predictable. Therefore there is room for flexibility and diversity in funding models for these services. Non-portable cost centres provide the greatest degree of protection, but hospitals which are strongly committed to hemophilia comprehensive care can fund this activity through their global budgets. In this case, the hospital must be prepared to provide resources sufficient to allow the Program to meet accreditation standards.