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Blood Transfus. 2010 July; 8(3): 170–177.
PMCID: PMC2906193

The procedures for authorisation and accreditation of Transfusion Structures and blood donation centres: what are the requisites? The experience of the Transfusion Service and AVIS blood donation centres in Ravenna

Abstract

Background

The system of accreditation of Italian transfusion structures (Transfusion Services and blood donation centres, these latter being managed by voluntary associations) guarantees the National Health Service that the service provided to citizens, patients and donors who use these structures, is correctly authorised, meets further, additional requisites relative to the quality of health care, and that these are documented and controlled during a formal audit.

Materials and Methods

We present here the experience gained, in the period 2007–2009, by the Transfusion Service of the local health authority of Ravenna and of the AVIS blood donation centres in the Province of Ravenna (Italy). These blood donation centres are managed in the context of a stipulated arrangement in which agreement was reached concerning not only the purposes, but also the quality requirements of the blood product collection, the operative methods, and the indicators and surveillance of non-conformities, in order to monitor and improve the blood supply system in the province.

Results

Our data show that, over time, there was a improvement in the distribution of collection of whole blood across the days of the week and better training of staff, as demonstrated by a reduction in non-conformities. Analysis of the data encouraged the identification of a new organisation with computerisation of the blood donation centres and their progressive merging.

Conclusions

There are numerous, precise legislative and technical indications to guarantee the quality of performances in transfusion medicine, from the collection of blood to its allocation. These indications constitute a qualified basis for the development of accreditation models whose final validation is the duty of specifically designated regional and national institutions.

The procedure for obtaining accreditation, planned and carried out uniformly by the Transfusion Service and the voluntary association’s donation centres was an occasion for professional staff to improve the quality of the services delivered. Collectively, these aspects have increased transparency and improved the system of blood supply in the province of Ravenna.

Keywords: Transfusion Services, Blood donation centres, Audit

Introduction

All health care facilities, whether public or private, which deliver health care services must be authorised to do so and this authorisation can only be granted if the facilities fulfil certain requisites, related, for example, to structure, plant design and equipment, for the delivery of services on behalf of the National Health Service. Accreditation is dependent on meeting additional requirements to those necessary for authorisation; these additional requirements are related to the quality of the health care and the ways of assessing this quality2.

The requisites for accreditation are additional to and different from the minimum requirements for authorisation, which are ex ante requisites; fulfilment of the general and specific requisites for accreditation usually guarantees good performances. The general requisites concern ‘virtuous’ organisational aspects, while the specific requisites are centred on the adequacy of the necessary professional skills and monitoring of each discipline in order to document outcome data, volumes produced and results achieved.

The legislative process of accreditation is applicable to hospital transfusion structures (Transfusion Services) and community ones (blood donation centres), the former being managed by Health Care Authorities and the latter by voluntary associations3.

Voluntary associations, which, in Italy, supply more than 50% of all blood components to the National Health Service, are required to agree with and guarantee the fulfilment of the same quality and efficiency criteria as those of the Health Authorities, with respect to both careful financial management and obligations to citizens and all those who receive products from the Transfusion Service, including industry for plasma processing, as the producer of blood derivatives.

The obligations and shared responsibility, laid out by legislation, of the Transfusion Services with regards to collection of blood products by voluntary associations makes the blood supply system a complicated structure to govern, although uniform and skilled. The duties set out in the written conventions between associations and federations of blood donors and local Health Authorities constitute the fundamental and strategic basis for every aim of the blood supply system4,8,9,10,13,14.

Materials and Methods

Three years ago, the Local Health Authority of Ravenna decided to set up and carry out a joint accreditation process, including agreement between the Transfusion Service and the AVIS blood donation centres on validated and homogeneous methods of selecting donors and collecting whole blood and plasma.

This goal was explicitly stated in the convention drawn up between the voluntary association and the Local Authority, in accordance with the Blood and Plasma Plan of the Region of Emilia-Romagna1. The Transfusion Service of the Province of Ravenna represents a notable component of the Region’s blood system, being responsible, each year, for the collection of about 28,000 units of whole blood and the performance of 9,000 productive apheresis procedures.

The characteristics qualifying blood components, which must be guaranteed and documented in every blood donation centre, in compliance with general requisites for authorisation and additional requisites for accreditation must include those necessary by law and those based on indications from Scientific Societies811. The main requisites used to plan the homogeneous performance of activities in common were:

  • - programming the collection of blood, compatible with the plans for regional and national self-sufficiency for blood components and plasma derivatives, by the Province’s Blood and Plasma Planning Committee, which regional legislation requires in Emilia-Romagna1;
  • - preparation of documents concerning operative procedures, which must be validated, methods and criteria for selecting donors16, with attention given to the management of organisational emergencies and adverse reactions in donors;
  • - correct and full information and education of donors regarding the donation and his or her responsibilities in relation to giving informed consent to the donation;
  • - definition of the skills required by the health care staff and their roles within the blood donation centre, with documentation of training activities carried out guaranteeing the acquisition and updating of skills; the voluntary association’s Health Care Director and the Quality Assurance Officer of the blood donation centre have particularly important organisation roles to play in this respect, as set out in legislative decree n. 208;
  • - definition of correct storage and transport;
  • - verification of the suitability of the technological resources, the methods of provision and management of materials and instruments used;
  • - methods for checking conformities and records of non-conforming products and situations;
  • - monitoring of activities and products, through the collection of data, sent by a systematic information flow, which can be used by the management of the Transfusion Service for controls and audits directly in the collection sites;
  • - planning the days of collection, which must be correctly balanced between the qualified resources available and the volume of the collection activity;
  • - guaranteeing the effective exchange of information between Transfusion Services and associations/federations of donors, which is important for the correct performance of processes and activities, and ensuring that defined methods of communication are systematically fulfilled15.
  • - records of non-conforming situations.

Results

Regular meetings, every 3 months, of the Province’s Blood and Plasma planning committee, as the site of governance, has enabled the aims of self-sufficiency to be analysed and agreed for each day of the week. The data show that in 2007 most of the donations were collected on Sundays (Figure 1) and that in 2008–2009 there was an increasingly homogeneous distribution throughout all the days of the week (Figure 2), ensuring a useful supply of products, particularly with respect to labile blood components such as platelets.

Figure 1
Percentage distribution of donations made during the week: 2007
Figure 2
Percentage distribution of blood donations made during the week: 2008 vs 2009

The nomination of a Quality Representative from among the staff of the voluntary association, in accordance with a law enacted in 200710, enabled the definition of the parameters for qualifying instrumental and material resources in the blood donation centres, but also of how to improve the qualification of the staff responsible for selection of donors and collection of blood products, who are involved in writing the operative procedures and instructions. The association also established a Quality Group which interacted with the Quality Representative of the Transfusion Service and analysed the quality system methods in depth. (Table I).

Table I
Planning aims

A questionnaire on satisfaction distributed to the association’s health care staff focused on the supply and interest in training and planning of updating, in relation to the process of blood collection, in common with the Transfusion Service (Table IIA, IIB, IIC)

Table IIA
Training requirements of the AVIS medical staff
Table IIB
Training requirements of the AVIS technical staff
Table IIC
Training requirements of the AVIS nursing staff

Controls by the Transfusion Service’s doctors, carried out in the community blood donation centres on the basis of a check-list of agreed requisites, enabled the correct performance of the collection procedures to be evaluated ‘on site’ (Table III).

Table III
Verification of the blood donation sites

The monitoring of non-conformities showed that better training of the staff led to higher quality performances, as demonstrated by the decrease in non-conformities in the blood donation centres over time (Table IV); besides revealing a continuously improving trend, this monitoring also enabled the introduction of an improvement action.

Table IV
Non-conformities recorded in the period from 2007 to 2009

The improvement action started from an analysis of the non-conformities and from the difficulty in having health care staff for more than 700 sessions in the community to collect blood products. Furthermore, some complaints received indicated that the training of the association’s staff was, in some cases, inadequate. The analysis of the number of sessions and the low number of donations per session, together with the opportunity given by the computerisation of the donation centres, led to a rational merger of the centres, choosing those considered most suitable. This enabled the number of sessions to be planned for each centre (Table V) so that the number of donations/bed made the sessions efficient while still being carried out in period compatible with the time of the subsequent processing of the blood.

Table V
Analysis of the number of blood donations sessions 2008–2009

The overall reduction of 30% of the sessions also makes the training of the blood collection team easier and improves the selection of donors by the staff, who become better qualified.

Conclusions

It is essential that Transfusion Services and voluntary associations agree on the fundamental values of the blood supply system and define the aims to reach in the context of national and regional planning. The different training, experiences and sensitivity of the members of the voluntary associations working in blood donation centres and the staff of Transfusion Services can sometimes make this sharing of values difficult and it is only the awareness of professional and legislative obligations that guides the search for agreed solutions.

Professionalism is fundamental for resolving situations of uncertainty and the precise training and trust of health care staff are at the basis of the quality of the product. The world of blood donors, together with Health Care Authorities, has undergone important changes in recent years and the need for a qualified blood supply system must be matched by the highest possible level of vocational skills: the professional must be able to supply a scientifically and professionally correct interpretation of the intent of the legislator as well as of technical and scientific evidence.

The process started, and in part already consolidated, in Ravenna Health Authority has laid the basis for subsequent unification, in Greater Romagna, of the blood system into a “Transfusion Workshop” where the productive activities related to blood and blood components will be gradually concentrated. It is precisely this new organisation that requires an accredited quality system that can define and validate standards for processes and products. The system must be robust and practical, as well as clear and verifiable by all the professionals involved.

References

1. Approvazione Piano Sangue e Plasma regionale triennio 2008–2010. (proposta della Giunta regionale in data 25 febbraio 2008, n. 207) Bollettino Ufficiale Regione Emilia-Romagna N.59, 8 May 2008.
2. Decreto del Presidente della Repubblica 14 gennaio 1997. Approvazione dell’atto di indirizzo e coordinamento alle regioni e province autonome di Trento e di Bolzano, in materia di requisiti strutturali, tecnologici ed organizzativi minimi per l’esercizio delle attività sanitarie da parte delle strutture pubbliche e private. Gazzetta Ufficiale della Repubblica Italiana, n. 42, 20 February 1997.
3. Decreto del Presidente del Consiglio dei Ministri 01.09.2000. Atto di indirizzo e coordinamento in materia di requisiti strutturali, tecnologici ed organizzativi minimi per l’esercizio delle attività sanitarie relative alla medicina trasfusionale. Gazzetta Ufficiale della Repubblica Italiana, n. 218, 18 September 2000.
4. Legge 21 Ottobre 2005, n. 219. Nuova disciplina delle attività trasfusionali e della produzione nazionale di emoderivati. Gazzetta Ufficiale della Repubblica Italiana, n. 251, 27 ottobre 2005
5. Direttiva del Parlamento Europeo e del Consiglio 2002/98/CE del 27 gennaio 2003, che stabilisce norme di qualità e di sicurezza per la raccolta, il controllo, la lavorazione, la conservazione e la distribuzione del sangue umano e dei suoi componenti e che modifica la direttiva 2001/83/CE. Gazzetta Ufficiale dell’Unione Europea, n. L 33, 8 February 2003.
6. Direttiva della Commissione Europea 2005/61/CE del 30 settembre 2005, che applica la direttiva 2002/98/CE del Parlamento europeo e del Consiglio per quanto riguarda le prescrizioni in tema di rintracciabilità e la notifica di effetti indesiderati ed incidenti gravi. Gazzetta Ufficiale dell’Unione Europea, n. L 256, 1 October 2005.
7. Direttiva della Commissione Europea 2005/62/CE del 30 settembre 2005, recante applicazione della direttiva 2002/98/CE del Parlamento europeo e del Consiglio per quanto riguarda le norme e le specifiche comunitarie relative ad un sistema di qualità per i servizi trasfusionali. Gazzetta Ufficiale dell’Unione Europea, n. L 256, 1 October 2005.
8. Decreto Legislativo 20 dicembre 2007, n. 261. Revisione del decreto legislativo 19 agosto 2005, n. 191, recante attuazione della direttiva 2002/98/CE che stabilisce norme di qualità e di sicurezza per la raccolta, il controllo, la lavorazione, la conservazione e la distribuzione del sangue umano e dei suoi componenti. Gazzetta Ufficiale della Repubblica Italiana, n. 19, 23 January 2008.
9. Decreto Legislativo 9 novembre 2007, n. 207. Attuazione della direttiva 2005/61/CE che applica la direttiva 2002/98/CE per quanto riguarda la prescrizione in tema di rintracciabilità del sangue e degli emocomponenti destinati a trasfusioni e la notifica di effetti indesiderati ed incidenti gravi. Gazzetta Ufficiale della Repubblica Italiana, n. 261, 9 November 2007.
10. Decreto Legislativo 9 novembre 2007, n. 208. Attuazione della direttiva 2005/62/CE che applica la direttiva 2002/98/CE per quanto riguarda le norme e le specifiche comunitarie relative ad un sistema di qualità per i servizi trasfusionali. Gazzetta Ufficiale della Repubblica Italiana, n. 261, 9 November 2007.
11. Grazzini G, Alfano G, Gandini G, Garozzo G, Menichini I, Tomasini I.(Società Italiana di Medicina Trasfusionale e Immunoematologia). Standard di Medicina Trasfusionale. Edizioni SIMTI, 2007
12. Decreto del Ministero della Salute 21 dicembre 2007. Istituzione del sistema informativo dei servizi trasfusionali. Gazzetta Ufficiale della Repubblica Italiana, n. 13, 16 January 2008.
13. Decreto del Ministro della Salute 3 marzo 2005. Protocolli per l’accertamento della idoneità del donatore di sangue e di emocomponenti. Gazzetta Ufficiale della Repubblica Italiana, n. 85, 13 April 2005.
14. Decreto del Ministro della Salute 3 marzo 2005. Caratteristiche e modalità per la donazione del sangue e di emocomponenti. Gazzetta Ufficiale della Repubblica Italiana, n. 85, 13 April 2005.
15. Decreto 5 novembre 1996. Indicazioni per l’istituzione del Registro del sangue e del plasma in ciascuna regione e provincia autonoma. Gazzetta Ufficiale della Repubblica Italiana n. 292, 13 December 1996
16. Protocollo per la selezione del donatore. AUSL di Cesena, Forlì, Ravenna e Rimini. Rev. 4 of 3 June 2008.

Articles from Blood Transfusion are provided here courtesy of SIMTI Servizi