A certification/accreditation model for Haemophilia Centres in Italy

Abstract

Background

The Italian Association of Haemophilia Centres has developed a voluntary programme of professional accreditation of Haemophilia Centres, run by its members. Participation in the programme, which aims to foster staff involvement in clinical governance, includes both medical personnel and nurses.

Materials and methods

Accreditation is awarded provided the candidate Haemophilia Centre is able to adhere to a pre-established set of quality standards and meet a number of clinical and organisational requirements, previously defined on the basis of evidence-based medicine. Self-evaluation is the first step in the programme, followed by a site visit by a team of peer professionals experienced in quality auditing.

Results

The programme has so far involved 21 Italian Haemophilia Centres. The comparison between self- and peer-evaluation revealed less discrepancies for disease-related than for organisational requirements, the latter being met to a lesser degree by most Haemophilia Centres.

Discussion

This programme of professional accreditation developed by the Italian Association of Haemophilia Centres has the potential to describe, monitor and improve clinical and organisational performances in the management of patients with haemophilia and allied inherited coagulation disorders. It should also be seen as a contribution to the implementation of the strategy for improving professional governance in Haemophilia Centres.

Introduction

Improvement in the quality of health care delivery is a primary goal for the medical profession^1–5. In the past few years, the attainment of this goal has been attempted by means of several different institutional approaches, local and international, which in general focused on organisational and procedural aspects of health care delivery. These programmes pay relatively little attention to quality aspects of clinical management and, most importantly, do not succeed in involving in the process such key players as the medical and nursing professionals. As a consequence, they often fail to truly promote and implement clinical governance^6,7. For instance, the ISO 9000 family of standards, which was devised originally by the industry, is effective as a guideline, but its promotion as a standard “helps to mislead companies into thinking that certification means better quality, … [undermining] the need for each organization to set its own quality standards”⁸. On the other hand, Joint Commission International (JCI) evaluates organisational processes of hospitals as a whole, being less focused on professional aspects of clinical governance⁹. Accordingly, the staff involved in clinical management feel that these activities are imposed from above, and sometimes they see them as quite foreign to their medical practice.

In order to overcome these limitations, the Italian Association of Haemophilia Centres (AICE) convened a working group with the aim of developing a quality ascertainment programme focused on those clinical and organisational activities that are most appropriate for Haemophilia Centres (HCs), based on the direct involvement of the staff and on site visits by a team of professional peers. The ultimate goal of this programme was to award a certificate of accreditation by a learned professional association to those HCs which had reached a pre-established performance threshold. To attain this goal, the HCs had to demonstrate that they were able first to meet a number of clinical and organisational requirements, and then to focus on deficient aspects and so develop a suitable plan aimed to improve unsatisfactory performance. The early results of the accreditation programme at 21 Italian HCs are presented here, with special emphasis on the comparison between self-evaluation and the subsequent independent evaluation by an external team of professional peers.

Materials and methods

The process of professional accreditation developed and implemented by AICE followed these steps: self-evaluation was first carried out by each HC, based on adherence to a panel of standards previously defined by the an ad-hoc panel comprising clinicians and patients. Requirements were set on the basis of the best available clinical evidence and management guidelines¹⁰. After self-evaluation results were obtained, peer-evaluation was carried out by a team of professionals previously trained in the auditing process by external experts in the quality control of health care systems. Peer-evaluation was conducted by means of direct interviews with the staff during site visits conducted at the applicant HC, analysis of a random sample of at least 15 medical records and on-site auditing of the operating procedures. Adherence to each standard was evaluated by means of scores attributed to each requirement. The scores employed to express the degree of adherence to standards were 3 for full compliance (when all aspects of the standards were met); 2, for almost full compliance (when most aspects of the standard were met); 1, for partial compliance (when only some aspects of the standards were met); 0, for non-compliance (when no aspects of the standards were met) and NA for not applicable.

This report is based upon an evaluation of 21 Centres (Appendix 1) conducted by a team of 5 professionals (Appendix 2). Evaluation took into account requirements set for awareness, information and education of patients and their families (3 requirements); patient care (119 requirements); laboratory practice (33 requirements) and organisational aspects dealing with the daily activities of the HCs (32 requirements). All these criteria are consultable for Italian HCs on a web site¹⁰.

Appendix 1.

Haemophilia Centres participating in the AICE programme of professional accreditation

Appendix 2.

Peer professionals involved in the evaluation process of the AICE programme of professional accreditation

Results

Figure 1 summarises the overall results for the 21 HCs, obtained by comparing self- with peer-evaluation expressed in percentage of the maximal total score attainable for the whole panel of requirements. On average, self-evaluation gave slightly higher results than peer-evaluation (86 vs 82% of the maximal possible score), self-evaluation being lower in 3 HCs only.

Figure 1.

Comparison of self-evaluation (closed bars) with peer-evaluation (open bars) for 21 HCs (identified by capital letters).

Values are expressed as percentages of the maximal total score that could be obtained for the whole set of standards.

Analysis of adherence to each requirement did reveal varied results, of which a few representative examples are reported here. For instance, the requirements related to participation of HCs in national and/or regional registries of inherited and acquired bleeding disorders showed good concordance between self- and peer-evaluation (score 3: 86 vs 81%). On the other hand, for the criterion on the regular organisation, in collaboration with patient associations, of events for the education and training of patients and their families (including home therapy/self-infusion), the score assigned by peer-evaluation was higher than that assigned by self-evaluation.

Highly relevant requirements for the management of inherited coagulation disorders, such as the prescription of coagulation tests according to professional guidelines, was satisfactorily met by a large percentage of HCs, with a good agreement between self- and peer-evaluation. There was also a good degree of adherence related to the production of a written report on diagnosis within one month of the initial visit.

Other requirements were less frequently met. For instance, not all HCs provided 24-hour expert haemophilia medical cover and, for this criterion, there was a clear overestimation of performance in self-evaluation (Figure 2). On the contrary, for some requirements the score assigned by peer-evaluation was even higher than that assigned by self-evaluation: for instance, for the determination of the level of antibody titre in patients who developed inhibitors (score 3: 76 vs 81%) (Figure 3).

Figure 2.

Percent distribution of HCs providing 24-h expert medical cover for hemophilia patients.

Figure 3.

As for Figure 2, according to the capacity to provide the actual titre of the antibody in patients who develop inhibitors.

Under the heading of requirements related to periodical clinical and multi-disciplinary check-up, there was a good concordance between self- and peer-evaluation for the requirement for the organisation of patient check-ups at least once a year (score 3: 90 vs 81%). For the organisation of specific visits for patients characterised by particularly frequent bleeding episodes or complications such as inhibitors, arthropathy or chronic viral infections (score 3: 76 vs 71%) and for drafting a letter for the patients after each visit, with information about current clinical problems, recommended treatment regimens, results of relevant laboratory data and other tests such as imaging, there was also good concordance (score 3: 76 vs 71%).

On the other hand, less concordance was found between self- and peer-evaluation with regard to the network of clinical and specialised services needed to collaborate with the haemophilia team. Only a few HCs have in place specific formal agreements that regulate relationships with structures providing specialist services, and peer-evaluation revealed that standards were much less adhered to than declared on self-evaluation, especially in relation to formal agreements with clinicians expert in hepatology (score 3: 67 vs 29%), infectious diseases (score 3: 67 vs 29%) and physiotherapy/orthopaedics (score 3: 67 vs 24%).

For the 11 HCs with an internal laboratory, there was a high degree of adherence to the provision of all coagulation tests recommended by the standards: PT; APTT; thrombin time; search of lupus anticoagulant; factor VIII and factor IX assays; inhibitor screen; VWF antigen and ristocetin cofactor activity; fibrinogen and factor II, V, VII, X, XI, XII, XIII assays; platelet aggregation induced by ADP, collagen, adrenaline and ristocetin: (score 3: 91% both in self- and peer-evaluation). For the 10 HCs centres that have no internal laboratory and that rely on external laboratories to provide them with tests through formal agreements that regulate the relationship, self-evaluation was too optimistic with respect to the satisfaction of standards (score 3: 55% vs 0; score 2: 36% in both self- and peer-evaluation).

Discussion

The first consideration that stems from this programme of accreditation of Italian HCs by peer professionals is that, in comparison with other models of certification or accreditation, the medical teams under evaluation shared with peer evaluators a common language and attitude for tackling clinical problems, which greatly facilitated the auditing process. Peer involvement also helped to make mutually acceptable the final judgement made by the accreditation team concerning the performance of the HCs. Finally, the voluntary nature of this programme emphasises the direct involvement of participating physicians in the resilient affirmation of their role in the professional governance of their own HCs.

In general, self-evaluation shows a tendency to overrate the quality of performance in this study, in agreement with previous observations, even if the opposite pattern of results was also observed in some cases. For example, the radiological Pettersson score and the magnetic resonance score were not always performed for all children in the periodic clinical and multi-disciplinary check-ups, at variance with the statement made by some HCs. On the other hand, the prescription of some unusual tests of kidney function rather peculiar for patients with haemophilia B undergoing immune tolerance for FIX inhibitors (serum creatinine, proteinuria) was identified more frequently by the peer-evaluation board than actually declared in self-evaluation.

Special attention was paid in the accreditation programme not only to the preparation and updating of patient clinical records but also to the provision of written information addressed to patients’ family physicians, pediatricians and other specialists, in order to assure and optimise health care continuity. On these topics, peer-evaluation indicated that adherence to standards was often overestimated by the HCs. The discrepancies between self- and peer-evaluations might reflect some lack of documentation of the activity rather than lack of performing the activity. However, we believe that adequate and accurate documentation of daily professional activities does indeed reflect the best professional knowledge and practice, particularly in the context of team work. The critical aspects documented during on-site visits by peers were incorporated by the HCs, which were encouraged to develop a plan aimed to improve the quality of care, to be monitored regularly at least on a yearly basis.

The AICE professional accreditation programme proved to be flexible, so that it could be easily adopted in the different realities of Italian HCs. The programme also proved to be practically feasible, because auditing visits by peers could be concluded and completed within one working day. Like all the models of accreditation and certification, this programme is obviously not static and foresees, as mentioned above, updating of the set of requirements at regular intervals, in line with the progress of medical knowledge and corresponding practice guidelines.

In conclusion, the professional accreditation programme of AICE is proposing a methodology effective for promoting good clinical practice to identify critical aspects of medical processes and to provide an opportunity for the improvement of professional performance through the effect of peer pressure. Moreover, as an initiative started by professionals and not by external authorities and/or hospital administrators, it fosters the direct and resilient involvement of clinicians in the clinical governance of their HCs. Focusing on the professional aspects peculiar to haemophilia care is not an alternative but rather a complementary strategy to other models and programmes of certification and accreditation widely implemented in Europe, which mainly consider organisational and procedural aspects of health care delivery.