Institutional authorisation and accreditation of Transfusion Services and Blood Donation Sites: results of a national survey

Abstract

Introduction

The aim of the survey described in this article was to determine decisional and strategic factors useful for redefining minimum structural, technological and organisational requisites for transfusion structures, as well as for the production of guidelines for accreditation of transfusion structures by the National Blood Centre.

Materials and methods

A structured questionnaire containing 65 questions was sent to all Transfusion Services in Italy. The questions covered: management of the quality system, accreditation, conformity with professional standards, structural and technological requisites, as well as potential to supply transfusion medicine-related health care services. All the questionnaires returned underwent statistical analysis.

Results

Replies were received from 64.7% of the Transfusion Services. Thirty-nine percent of these had an ISO 9001 certificate, with marked differences according to geographical location; location-related differences were also present for responses to other questions and were confirmed by multivariate statistical analysis. Over half of the Transfusion Services (53.6%) had blood donation sites run by donor associations. The statistical analysis revealed only one statistically significant difference between these donation sites: those connected to certified Transfusion Services were more likely themselves to have ISO 9001 certification than those connected to services who did not have such certification.

Conclusions

The data collected in this survey are representative of the Italian national transfusion system. A re-definition of the authorisation and accreditation requisites for transfusion activities must take into account European and national legislation when determining these requisites in order to facilitate their effective applicability, promote their efficient fulfilment and enhance the development of homogeneous and transparent quality systems.

Introduction

Legislative decree (DLgs) n. 502 of December 30^th, 1992¹, and its subsequent modifications and integrations, called for the definition of the minimum structural, technological and organisational requisites for public and private structures to carry out health care activities, as well as the frequency of the controls to determine that the requisites continue to be fulfilled: a policy and coordination act, issued in agreement with the Standing Conference for relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano was to be prepared.

In application of the above-described general provisions, the Decree of the President of the Republic (DPR) of January 14^th, 1997² approved “the policy and coordination act of the Regions and the Autonomous Provinces of Trento and Bolzano, concerning the minimum structural, technological and organisational requisites for public and private structures to carry out health care activities”. This decree introduced the “minimum” qualitative requisites (also called “authorisation” requisites) necessary for any health care organisation to carry out its activities.

However, in order to be able to carry out health care activities “in the name of and on behalf of the National Health Service”, organisations must meet further requisites in addition, obviously, to the minimum requisites. In this case the organisation carrying out the activities can be “accredited” (for types and volumes of services, in relation to the needs expressed in regional health care plans).

Given the federalist arrangement of health care government in Italy, it should be appreciated that the issue of general and specific minimum/authorisation requisites for a given health care activity requires substantial and formal agreement between the State and Regions, in order to maximise the homogeneous applicability of the requisites throughout the country and to respect essential levels of assistance. Additional requisites - for accreditation - are, on the other hand, defined independently by the Regions/Autonomous Provinces; furthermore, the definition of the methods and procedures for managing the authorisation and accreditation processes is the prerogative of the Regions/Autonomous Provinces.

Transfusion activities were not provided for in the DPR of January 14^th, 1997². For this reason, the Decree of the President of the Council of Ministers (DPCM) of September 1^st, 2000³ subsequently emanated “the policy and coordination act concerning the minimum structural, technological and organisational requisites for carrying out health care activities relative to transfusion medicine” which, until the enactment of Law n. 219 of October 21^st, 2005⁴, was the fundamental reference for all processes of authorisation and accreditation regarding transfusion activities. It should be noted that the DPCM of September 1^st, 2000³ has been applied, both in form and in substance, only partially and only in some Regions and Autonomous Provinces. Likewise, more than 10 years after the issue of the DPR of January 14^th, 1997², the process for institutional accreditation of health care activities has only been partially activated in some Regions.

Since 2002, and in particular in the 3-year period from 2005 to 2007, there has been a particularly florid and impressive production of national and European Community legislation on transfusion matters and activities related to them, the likes of which had never been seen before^4–16. The body of legislation that has developed is, therefore, currently very complex with regards to the relations between European and national regulations, in particular because of the need to harmonise the acts transposing European directives with the provisions of existing national legislation.

European legislation on transfusion matters and related activities are strongly inspired by the social and ethical concepts of solidarity, voluntariness and periodicity of donations, as well as the fundamental principles of protecting the health of citizens through equality, transparency and the right to access to safe and systematically controlled services¹⁷. Great importance is also given to the principles of managing and controlling the specific care processes, in order that these have the purpose of guaranteeing high professional and organisational standards, as well as regulating the appropriateness of the clinical use of blood products.

In particular, Articles 19 and 20 of the “new discipline on transfusion activities and national production of blood derivatives” in Law n. 219 of October 21^st, 2005⁴ called for, respectively, a redefinition of the minimum structural, technological and organisational requisites and the issuing, by the National Blood Centre, of guidelines for the accreditation of transfusion activities¹⁸.

National legislation (Law 219/2005⁴, DLgs 261/2007¹⁶, and its related implementing measures) establishes that transfusion activities are managed exclusively at a public level, given the particularity and delicacy of the sector. Transfusion Services (for a definition, see Article 2, paragraph 1, letter e of DLgs 261/2007¹⁶) are specialist hospital services, organised according to planning documents of Regions and Autonomous Provinces and coordinated by the individual Regions through coordinating structures (“Regional Blood Centres”), as set out in Article 6, paragraph 1, letter c of Law 219/2005⁴. The term “Transfusion Services” includes “the structures and related peripheral organisational sites, including those for blood collection activities, foreseen by the current legislation according to regional organisational models, which are responsible in any way for the collection and control of human blood and its components, whatever their destination, as well as for their processing, storage, distribution and allocation when the products are destined for transfusion”. For this reason external blood donation sites (i.e., not in hospitals) whose authorisation is dependent on the hospital must not be confused with blood donation sites managed by associations (whose authorisation to collect blood donations is granted by the associations or federations of donors).

In fact, Italian legislation allows for the existence of “blood donation sites” not in hospitals which are managed by associations and federations of donors but work under the technical responsibility of the hospital Transfusion Services to which they refer (for a definition, see Article 2, paragraph 1, letter f of DLgs 261/2007¹⁶). These blood donation sites managed by donor associations, henceforth referred to as UDRA, are subject to authorisation regarding certain minimum requisites which, for these sites themselves, have never been specifically defined at a national level and must, therefore, be formulated during the application of Article 19 of Law 219/2005⁴. It is also important to note that the legislation on this matter states that the UDRA “may” be activated in accordance with regional planning and programming needs, with a view to guaranteeing a capillary diffusion of donation sites throughout the country and, therefore, facilitating the donation of blood and blood components with the purpose of achieving and maintaining regional and national self-sufficiency in these products.

The survey on which this study is based was designed by the Italian Society of Transfusion Medicine and Immunohaematology (SIMTI) and its results were presented at the National Conference of Transfusion Services¹⁹, which was held in Terrasini (Palermo, Italy) from May 28^th to 30^th, 2009. The aim of the study was to determine decisional and strategic factors useful for redefining the minimum structural, technological and organisational requisites for transfusion structures, as well as for the production of guidelines by the National Blood Centre for accreditation, by providing a picture of the current national transfusion system with regards to certification, accreditation, degree of conformity with professional standards and potential for delivering transfusion medicine services.

Materials and methods

In January 2009, a structured questionnaire (see appendix) comprising 65 questions (40 for Transfusion Services [TS] and 25 for the UDRA) was sent by e-mail to all the national Transfusion Services, asking them to reply within 2 weeks.

The questions were intended to determine the existence and number of related peripheral organisational sites and/or UDRA, whether these had standard operating procedures to ensure the quality and safety of the donation process, as well as, only for the TS, the type of transfusion medicine services supplied and conformity with one of the main mandatory requisites of DLgs n. 207 of November 9^th, 2007¹⁴ (identification of a person responsible for the haemovigilance system). Furthermore, for both the TS and the UDRA, questions were aimed at obtaining information on:

• - possession of certification of conformity with ISO 9001 standards and/or institutional and/or voluntary forms of accreditation;

• - whether critical processes and control indicators have been identified;

• - the presence of some structural and technological requisites aimed at guaranteeing the conformity of the processes of collection, processing, biological qualification and distribution of the blood components with organisational and professional standards, as well as with the mandatory and quality requisites;

• - periodic verification of customer satisfaction.

Univariate and multivariate analyses were conducted on all the questionnaires received, taking into consideration all the questions to which replies were provided. In order to be able to evaluate whether there were differences and/or variations depending on their different geographical locations, the TS were grouped into the following macro-areas according to the indications of the Italian National Institute of Statistics (ISTAT)²⁰:

• - North-East (Trentino Alto Adige, Veneto, Friuli Venezia Giulia, Emilia Romagna);

• - North-West (Piedmont, Valle d’Aosta, Lombardy, Liguria);

• - Centre (Tuscany, Umbria, Marche, Lazio);

• - South (Abruzzo, Molise, Campania, Apulia, Basilicata, Calabria);

• - Islands (Sicilia, Sardinia).

The percentage frequencies of the variables related to the different categories of questions were calculated and any differences evaluated by a chi-square test or Fisher’s exact test, where necessary. Furthermore, an analysis of multiple correspondences was performed, graphically representing the “distances” between some characteristics of the structures in order to demonstrate the requisites shared by several TS.

The characteristics chosen for the multivariate analysis were identified on the basis of the responses given to some questions considered, arbitrarily, suitable for showing the salient requisites of the TS with regards to: management of the quality systems and compliance with transfusion medicine standards²¹, and the structural, organisational and technical-professional profile: [i] Does the TS possess an ISO 9001 certificate? [ii] Does the TS have any other certificates? [iii] Has the Management of the TS identified the critical processes? [iv] Have control indicators for monitoring these processes been defined? [v] Is the TS a site for collecting haematopoietic stem cells from peripheral blood? [vi] Has the TS nominated a person responsible for the haemovigilance system? [vii] Does the area used for interviewing the potential donor safeguard his or her privacy? [viii] Is the quality of the analytic activities evaluated through participation in official proficiency testing systems? [ix] Are post-transfusion data recorded? [x] Are there standard operating procedures for notifying the relevant authorities of any adverse events related to donations? [xi] Is the satisfaction of donors, patients and wards analysed?

Given the asymmetrical nature of the quantitative variables, it was preferred to report the median as the central indicator and the minimum and maximum values as the range, since these data are definitely more representative than the mean.

The statistical analyses were carried out using Stata 10.1 software (StataCorp, TX, USA) and p values less than 0.05 are considered statistically significant.

Results

By prolonging the initial deadline from 2 to 5 weeks, responses were received from 183 (64.7%) of the 283 structures contacted (82% of the replies were by e-mail and 18% via fax). The data related to the adhesion of the Regions to the investigation showed a negative gradient from the Centre and North (with all the TS adhering to the investigation in Regions such as Trentino Alto Adige, Valle d’Aosta, Liguria and Umbria) towards the South (where none of the TS of Basilicata returned the questionnaire) and the Islands (Figure 1). The median percentage of responses (positive or negative) to the individual questions was 98.4%, with a range from 89.1 % (reply to the question on the use of therapeutic phlebotomy) to 100%.

Figure 1.

Percentage distribution, by Region, of the transfusion structures that responded to the questionnaire sent.

Transfusion Structures

Sixty-two percent of the TS (111/183) had external blood donations sites, with the maximum prevalence of this form of structure being found in the North-East (74.1%) and the minimum in the Islands (52.6%); the prevalence of TS with external blood donation sites was intermediate in the North-West (61.1%), Centre (62.8%) and South (58.3%) of Italy.

Seventy-one of the 183 TS (38.8%) declared that they had gained ISO 9001 certification, with marked differences according to their geographical location (North-West: 63.6%; North-East: 53.8%; Centre: 34.1%; South: 13.2%; Islands: 10.5%), again showing a negative gradient from North to South and Islands both for ISO 9001 certification and for other forms of accreditation (Regional institutional, European Federation for Immunogenetics [EFI], Foundation for the Accreditation of Cellular Therapy [FACT], Joint Accreditation Committee ISCT [International Society for Cellular Therapy] and EBMT [European Group for Blood and Marrow Transplantation], [JACIE] and Joint Commission International [JCI]) (Figure 2). Overall, 21.1% of the TS (35/183) had other forms of accreditation.

Figure 2.

Percentage distribution by ISTAT macro-areas of TS with ISO 9001 certification and completion of other professional or institutional accreditation systems.

With regards to the ISO 9001-certified TS, the analysis of the percentage distribution of the year of obtaining certification showed that the first TS (1.4% of those replying to the questionnaire) gained certification in 1995 and that the peak of ISO 9001 certification (21.4% of the TS which responded to the questionnaire) occurred in 2002, the year in which 47% of all certified TS reached this objective; the remaining 53% of the certified TS achieved this objective between 2003 and 2008.

The TS of the Region of Friuli Venezia Giulia were the only structures to have completed the procedure for Regional institutional accreditation, in the first few months of 2009. Table I reports the distribution of the type of quality system certification and forms of voluntary accreditation possessed by the Italian TS, divided according to ISTAT macro-area.

Table I.

Distribution by ISTAT macro-area of the type of certification of the quality system or other form of professional accreditation of the Italian transfusion structures.

Type of certification of quality system or professional accreditation	North-West		North-East		Centre		South		Islands		Total
	n	%	n	%	n	%	n	%	n	%	n	%
ISO 9001	35	63.6	14	51.9	15	34.1	5	13.2	2	10.5	71	38.8
EFI	9	16.4	6	22.2	2	4.5	0	0.0	1	5.3	18	9.8
JCI	7	12.7	2	7.4	1	2.3	0	0.0	0	0.0	10	5.5
JACIE	2	3.6	1	3.7	0	0.0	0	0.0	0	0.0	3	1.6
FACT	2	3.6	0	0.0	0	0.0	0	0.0	0	0.0	2	1.1

Legend:

n: number of transfusion structures that replied positively to this question; %: percentage of transfusion structures that replied positively to this question out of the total number of structures that replied; ISO 9001: possession of ISO 9001 certification; EFI: possession of European Federation for Immunogenetics (EFI) accreditation; JCI: possession of Joint Commission International (JCI) accreditation; JACIE: possession of Joint Accreditation Committee ISCT (International Society for Cellular Therapy) and EBMT (European Group for Blood and Marrow Transplantation) (JACIE) accreditation; FACT: possession of Foundation for the Accreditation of Cellular Therapy (FACT) accreditation.

Bivariate statistical analysis of the responses to the individual questions by the TS showed some statistically significant differences (summarised in Table II) between the 71 TS with ISO 9001 certification (TS-ISO) and the 112 TS without this certification (TS-NO-ISO). These differences concern the existence of some organisational, technological and quality system requisites (identification of the critical processes, definition of control indicators for monitoring the critical processes, presence of an emergency trolley and defibrillator in the area dedicated to blood collection, staff responsible for collecting blood donations having a basic life support [BLS] qualification, monitoring the temperature of blood during transport from the donation site to the processing site, evaluation of the quality of the analytic activities through participation in official proficiency testing systems, analysis of the satisfaction of donors, patients and wards) as well as the type of transfusion medicine services supplied (collection of haematopoietic stem cells, therapeutic apheresis).

Table II.

Transfusion structures: bivariate analysis of positive responses to the questions and possession of ISO 9001 certification (statistically significant differences) and percentage of positive responses to the question out of the total responses.

Positive response to the question:	ISO 9001 YES (%)	ISO 9001 NO (%)	p	% total
Has the Management of the TS identified the critical processes?	100	89	0.005	93.3
Have the control indicators for monitoring these processes been defined?	98.6	77.1	<0.001	85.4
Is the TS a site for collection of haematopoietic stem cells from peripheral blood?	45.1	26.4	0.009	33.7
Does the TS perform therapeutic apheresis?	87	65.1	0.001	73.7
Is there an emergency trolley in the area dedicated to blood collection?	97.2	87.4	0.023	91.2
Is there a defibrillator in the area dedicated to blood collection?	72.9	45.5	<0.001	56.0
Do the staff involved in collecting blood have a Basic Life Support qualification?	90.1	67.3	<0.001	76.2
Is the temperature of collected blood monitored during its transport from the collection site to the processing site?	72.7	48.3	0.023	57.0§
Is the quality of analytic activities evaluated through participation in official systems of proficiency testing?	88.4	61.1	<0.001	71.8
Is the satisfaction of donors, patients and wards analysed?	97.2	49.1	< 0.001	68#

Legend:

ISO 9001 YES: percentage of transfusion structures in possession of ISO 9001 certification; ISO 9001 NO: percentage of transfusion structures not in possession of ISO 9001 certification; % total: percentage of positive responses out of total responses; TS: transfusion structure;

^§this question was applicable to 93/183 TS, equivalent to 50.8% of the TS that adhered to the survey;

^#the last analysis of customer satisfaction was performed within the 2 years preceding the date of the current survey.

The Management of the TS had identified the critical processes in 100% of the TS-ISO and in 89% of the TS-NO-ISO (p=0.005); the control indicators for monitoring these processes had been identified in 98.6% of the TS-ISO and in 77.1% of the TS-NO-ISO (p=0.001).

Multivariate analysis of the data, aimed at determining the percentage distributions in ISTAT macro-areas of the TS in which definition of control indicators for monitoring critical processes was or was not associated with an ISO 9001 certificate or other form of accreditation (institutional or voluntary) and the TS without these characteristics showed that there was a high concentration of the “indicators defined - ownership of certification/accreditation” pairing in the North-West (69.8%), North-East (61.5%) and Centre (34.1%), while the TS in which the above-mentioned control indicators had not been defined were more frequent in the Islands (Figure 3A).

Figure 3.

Percentage geographic distribution by ISTAT macro-areas of transfusion structures characterised by:

• - an association between “definitions made of control indicators for monitoring critical processes and possession or not of ISO 9001 certification or other form of accreditation (professional or institutional)” and by “lack of definition of control indicators for monitoring critical processes” (A);
• - an association between carrying out therapeutic apheresis and possession of ISO 9001 certification and/or other form of accreditation (B);
• - collection of haematopoietic stem cells and therapeutic apheresis (C);
• - association between “collection of haematopoietic stem cells and possession or not of ISO 9001 certification and/or other form of accreditation (professional or institutional)” and by “lack of collection of haematopoietic stem cells” (D).

Peripheral blood haematopoietic stem cells were collected in 61/183 TS (33.7%), more frequently in the TS-ISO (32/71; 45.1%) than in the TS-NO-ISO (29/110; 26.4%) (p=0.009). Almost all the centres in which haematopoietic stem cells were collected (56/61) were included in a haematopoietic stem cell transplantation programme; furthermore, 33/61 of these TS (54%) had ISO 9001 certification, 16/61 (26.2%) had EFI accreditation, and 24/61 (41.4%) had some other form of accreditation (Regional institutional, FACT, JCI). Only 11 of the 56 TS that collect haematopoietic stem cells and are included in a haematopoietic transplantation programme were already accredited by JACIE (20%), in one TS (2%) the accreditation process was underway at the time of the investigation, while the remaining 44 TS (78%) did not have this accreditation.

In bivariate analysis there were no statistically significant differences between TS-ISO and TS-NO-ISO with regards to the capacity to deliver other transfusion medicine services, such as therapeutic phlebotomy, transfusion/infusion therapy, autotransfusion, and the diagnosis, prevention and treatment of haemolytic disease of the newborn; these activities were, in fact, performed in between 80.2% (haemolytic disease of the newborn: TS-NO-ISO) and 100% (autotransfusion: TS-ISO) of the TS.

Therapeutic apheresis was performed in 129 of the 175 TS that replied to the questionnaire (73.7%) and in a higher percentage in the TS-ISO (87%) in comparison to the TS-NO-ISO (65.1%) (p=0.001). Forty-seven percent of the TS that carried out therapeutic apheresis had ISO 9001 certification and 27% were also accredited by one of the above-mentioned accreditation bodies.

The association between offering therapeutic apheresis and having ISO 9001 certification and/or other forms of accreditation (professional or institutional) was strongest in TS in the North-West (69.8%) and decreased in the North-East (60%), Centre (22.5%), South (8.1%) and Islands (16.7%) (Figure 3B); therefore, in the North-West 75.5% of the centres stating that they carried out therapeutic apheresis had ISO 9001 certification and/or other forms of accreditation, 78.9% in the North-East, 40.6% in the Centre, 16.7% in the South and 27.3% in the Islands.

The TS in which haematopoietic stem cells and therapeutic apheresis were carried out were predominantly concentrated in the Centre and North, where these procedures were carried out in more than 40% and 70%, respectively, of the TS present (Figure 3C).

A similar territorial distribution of TS was found regarding the association of “collection of haematopoietic stem cells” and “possession or not of ISO 9001 certification and/or other forms of accreditation (professional or institutional)” and the lack of haematopoietic stem cell collection. The pairing “haematopoietic stem cell collection - possession of certification/accreditation” was present in 32.7% of the TS in the North-West, in 29.6% of those in the North-East, in 20.5% in the Centre, but in only 11.1% of the TS in the South and 5.3% of those in the Islands (Figure 3D); consequently, 82% of the TS in the North-West that declared that they collected haematopoietic stem cells had ISO 9001 certification or another form of accreditation, while this percentage dropped to 73% in the NorthEast, 47.4% in the Centre, 33.3% in the Islands and to 66.7% in the South. The percentage of TS that collected haematopoietic stem cells without having either certification or accreditation only exceeded in the Centre (22.7%) and in the Islands (10.5%) that of the TS which, in the same macro-areas, were characterised by the association “haematopoietic stem cell collection - possession of certification/accreditation” (20.5% and 5.3%, respectively).

There were no statistically significant differences between the TS-ISO and the TS-NO-ISO concerning the identification of a reference figure for the haemovigilance system set out in the DLgs n. 207 of November 9^th, 2007¹⁴, the presence of areas dedicated to the selection of donors able to safeguard their privacy, and the presence in the area dedicated to the collection of blood of equipment for the treatment of donation-related adverse reactions (Table III).

Table III.

Transfusion structures: bivariate analysis of positive responses to the questions and possession of ISO 9001 certification (not statistically significant differences) and percentage of positive responses to the question out of the total responses.

Positive reply to the question:	ISO 9001 YES (%)	ISO 9001 NO (%)	p	% total
Has the TS nominated a person responsible for the haemovigilance system?	87.0	77.3	0.108	81.0
Is the candidate donor’s privacy ensured in the area dedicated to his/her interview?	100	95.5	0.068	97.2
Are there devices for treating donor-related adverse reactions in the area dedicated to blood collection?	100	99.1	0.423	99.5
Is the area dedicated to processing blood separate from that dedicated to performing laboratory investigations?	97.2	97.3	0.963	97.3
Is the equipment in the TS tried and tested?	100	99.1	0.425	99.5
Is the equipment in the TS calibrated and periodically serviced?	100	97.3	0.164	98.4
Does the TS have electronic scales for the collection of blood?	100	95.5	0.070	97.3
Are the collection scales interfaced with a dedicated information system?	57.8	44.0	0.072	49.4
Are the critical parameters relative to the collection phase tracked and made available for the processing stage?	87.3	76.2	0.064	80.6
Are post-transfusion data recorded?	88.7	85.5	0.526	86.7
Are there operating procedures for notifying the competent authorities of adverse events related to transfusion therapy?	85.7	77.9	0.198	81.0
Are there operating procedures for notifying the competent authorities of adverse events related to donation of blood?	77.1	64.2	0.067	69.3

Legend:

ISO 9001 YES: percentage of transfusion structures in possession of ISO 9001 certification; ISO 9001 NO: percentage of transfusion structures not in possession of ISO 9001 certification; % total: percentage of positive responses out of total responses; TS: transfusion structure;

In contrast, as already shown in Table II, the availability of a trolley for emergencies and of a defibrillator in areas dedicated to blood collection, as well as the presence of staff trained in BLS in the same areas, were characteristics distinguishing, in a statistically significant manner, the TS-ISO from the TS-NO-ISO. The TS with defibrillators in the blood collection areas are distributed in a markedly heterogeneous manner through the country, with a higher concentration in the North-West (74.1%), North-East (70.4%) and Centre (59.2%) than in the South (31.6%) and the Islands (26.3%), and with a similar gradient as that described for the control indicators for monitoring critical processes (Figure 4A). The association between the presence of a defibrillator in the area dedicated to the collection of blood and the possession of ISO 9001 certification or other forms of accreditation (voluntary or institutional) shows the same decreasing trend from North to South and the Islands, while, conversely, the trend in the lack of a defibrillator in the area used to collect blood increases from North towards South and the Islands (Figure 4B).

Figure 4.

Percentage distribution by ISTAT macro-area of transfusion structures characterised by:

• - definition made of control indicators for monitoring critical processes and the presence of a defibrillator in the area dedicated to blood collection (A);
• - association between “presence of a defibrillator in the area dedicated to the collection of blood and possession or not of ISO 9001 certification or other form of accreditation (professional or institutional)” and “lack of defibrillator in the area dedicated to blood collection” (B).

Bivariate analysis did not show statistically significant differences between TS-ISO and TS-NO-ISO with regards to the replies given to the last 12 questions in Table III. However, the availability of electronic scales for blood collection, their interface with a dedicated information system, tracking of the critical parameters of the collection process and the existence of standard operating procedures for notifying donation-related adverse events to the relevant authorities were more frequent in the former type of TS than in the latter, with the differences approaching statistical significance.

Finally, multivariate analysis of the correspondences (Figure 5) highlighted the different distribution by ISTAT macro-area of the positive or negative responses to the 11 questions considered useful for identifying the TS that comply with the priority requisites regarding organisation and quality system management, as well as professional and technological-structural issues. There is a fairly clear separation between the TS that replied positively to the 11 selected questions and those that replied negatively.

Figure 5.

Multivariate analysis of correspondences between ISTAT macro-areas and distribution of the positive and negative responses to the 11 questions considered, arbitrarily, suitable for identifying the transfusion structures possessing the priority organisational, professional, technological and structural requisites.

The concentration of responses (positive or negative) to the questions around a specific ISTAT macro-area causes the characteristic features. The positive responses to the questions are distributed in the left lower and upper quadrants, where the following ISTAT macro-areas are located: North-West, North-East and Centre. The negative responses to the questions are distributed in the right lower and upper quadrants of the graph where the following ISTAT macro-areas are located: Islands and South.

The fulfilment of the above-mentioned requisites is concentrated in the left-hand part of the graph and is associated mostly with TS in the North; in particular, for example, the collection of haematopoietic stem cells is strongly associated with TS in the North-West. The TS in the Centre are in an intermediate situation with regards to the presence or absence of the above-mentioned requisites; the lack of fulfilment of these requisites is, on the other hand, a characteristic associated with TS in the South of Italy and in its Islands.

Blood donation sites run by blood donor associations

Of the 183 TS, 96 (53.6%) reported having UDRA, for a total of 885 such sites distributed through the country (range: 1–136, median: 3), with a higher concentration in the Centre (n=328) and the North-West (n=288), macro-areas which account for 70% of all the UDRA, followed by the South (n=137), the Islands (n=114) and the North-East (n=18).

Overall, 12.5% of the TS with UDRA (12/96) declared that these latter have ISO 9001 certification; this percentage was 4.8% (3/63) for the UDRA connected to the TS-NO-ISO and 27% (9/33) for those connected to the TS-ISO (p=0.002).

Excluding the presence of electronic scales for the collection of blood (p=0.046), bivariate analysis (Table IV) did not show any other statistically significant differences between UDRA associated with TS-ISO or TS-NO-ISO with regards to the organisational, technological and quality system management requisites under investigation in this part of the survey. However, the availability of a defibrillator in the area used to collect blood was more frequent in UDRA associated with TS-ISO than in those connected to TS-NO-ISO, with the difference approaching statistical significance (p=0.08) (Table IV).

Table IV.

Peripheral donation sites: bivariate analysis of positive responses to the questions and possession of ISO 9001 certification (by the reference transfusion service) and percentage of positive responses to the question out of the total responses.

Positive reply to the question	ISO 9001 YES (%)	ISO 9001 NO (%)	p	% total
Does the Transfusion Structure (TS) have peripheral donor sites run by donor associations (UDRA)?	48.5	57.8	0.229	54.2
Has the TS supplied the UDRA with the technical and health-care standard operating procedures to ensure the quality and safety of the whole collection process?	90.9	90.3	0.926	90.5
Have the critical processes of the external collection activities been identified?	84.9	79.4	0.513	81.3
Have the control indicators for monitoring these processes been defined?	78.8	73.0	0.535	75
Is the candidate donor’s privacy ensured in the area dedicated to his/her interview?	100	92.1	0.161	94.8
Are there devices for treating donor-related adverse reactions in the area dedicated to blood collection?	93.9	93.7	0.956	93.8
Is there an emergency trolley?	72.7	62.3	0.308	66.0
Is there a defibrillator available?	28.1	13.3	0.082	18.5
Do the staff involved in collecting blood have a Basic Life Support qualification?	53.3	42.6	0.335	46.2
Is the equipment in the UDRA tried and tested?	100	88.3	0.090	92.2
Is the equipment in the UDRA calibrated and periodically serviced?	96.7	86.7	0.262	90.0
Does the UDRA have electronic scales for the collection of blood?	84.8	65.6	0.046	72.3
Are the collection scales interfaced with a dedicated information system?	12.1	8.1	0.715	9.5
Are the critical parameters relative to the collection phase tracked and made available for the processing stage?	51.5	50.8	0.949	51.1
Is post-donation refreshment offered?	97.0	98.4	0.999	97.9
Does the UDRA have a refrigerator for transporting the blood to the TS?	84.9	82.3	0.748	83.2
Is the temperature of the blood monitored during its transport?	59.4	61.3	0.857	60.6
Does the UDRA have a standard operating procedure for eliminating special waste?	90.6	91.9	0.999	91.5
Is the satisfaction of the donors coming to the UDRA analysed?	42.4	29.0	0.189	33.7#

Legend:

TS: transfusion structure; UDRA: peripheral donation site run by donor associations; ISO 9001 YES: percentage of reference transfusion structures in possession of ISO 9001 certification; ISO 9001 NO: percentage of reference transfusion structures not in possession of ISO 9001 certification; % total: percentage of positive responses out of total responses;

^#the last analysis of customer satisfaction was performed within the 2 years preceding the date of the current survey.

Finally, an analysis of the satisfaction of the donors, patients and wards was carried out at least biannually also in the UDRA.

Conclusions

The data collected in this survey can be considered representative of the national transfusion situation, since they came from about 65% of the TS making up the Italian blood system. Nevertheless, one limitation of the study could be the total lack of information on TS from a whole Region (Basilicata) and, overall, from about one-third of all the TS (with a strong North-South gradient), which did not adhere to this study promoted by SIMTI. The median percentage of replies to the single questions of the survey, which was very close to 100%, shows that the structure of the questionnaire, despite the number of items of information requested, was suitable for reaching the pre-established aims.

The capillary spread of the national transfusion system, demonstrated by the high percentage of TS that had their own external collection site and/or UDRA, undoubtedly reveals the need for some rationalisation, but is also a dual point of strength of Italian transfusion medicine both with regards to achieving and maintaining self-sufficiency and with regards to the appropriateness of the clinical use of blood components and plasma-derived drugs, guaranteed by specialist hospital services that make up the transfusion network²².

About 40% of the structures that make up the transfusion network have ISO 9001 certification, but the ISO model is not the only model of quality system adopted by Italian TS. Other models are used, among which the most common are the EFI and JCI professional accreditation systems; there are, however, notable differences related to the geographical location of the TS, giving rise to the negative North-South gradient.

This gradient was highlighted by the bivariate analysis (and confirmed by the multivariate analysis of correspondences), which showed the direct relation between the adoption of a quality system and the technical, professional, organisational and structural profile of the TS, as well as fulfilment of mandatory requisites and standards for transfusion medicine. The level of specialisation of certified and/or accredited TS was higher, as shown by the capacity of these TS to provide certain health care services such as therapeutic apheresis and the collection of haematopoietic stem cells. In over 90% of centres this latter service is performed within the context of a haematopoietic stem cell transplantation programme, which requires conformity with specific voluntary standards (FACT, JACIE, EFI), leading to changes in the relevant processes by the TS that are involved in such programmes.

The results of the multivariate analysis mentioned above led to the hypothesis that the adoption of models of quality system management can act as a driving force for the acquisition of other technical, professional, organisational and structural requisites, arbitrarily considered priority, but closely and reciprocally associated among each other and able to delineate the salient features of TS which are closest to the model identified by the European regulations.

This survey also picked up some non-conformities in both TS and UDRA. These non-conformities occurred at different frequencies and involved: (i) definition of the control indicators for monitoring critical processes (TS); (ii) availability of technical and health-related standard operating procedures in the UDRA to ensure the quality and safety of the whole process of blood collection; (iii) identification of the critical processes within the setting of external collection of blood and definition of the control indicators to monitor them; (iv) identification of a person responsible for haemovigilance (TS); (v) guaranteeing privacy during the process of donor selection (TS and UDRA); (vi) availability of an emergency trolley (UDRA), defibrillators and staff trained in BLS (TS and UDRA) in the area where the blood collection takes place; (vii) availability of electronic scales for the collection of blood (TS and UDRA); (viii) an interface between the scales and a dedicated information system (TS and UDRA); (ix) tracking the critical parameters of the blood collection process to use them during the blood processing (ST and UDRA); (x) transport of the blood from the collection area to the processing area (TS and UDRA); (xi) participation in official systems of proficiency testing for the evaluation of the quality of analytic activities (in this case the adjective “official” could have introduced a bias in interpretation); (xii) recording of follow-up information after the transfusion (TS); (xiii) availability of standard operating procedures for notifying adverse events related to the transfusion therapy or donation to the competent authorities (TS); (xiv) analysis of customer satisfaction.

A further limitation of this survey could be the lack of inclusion of questions capable of picking up the degree of diffusion of validation processes in the TS^15,21, that is, preparation of documented and objective tests showing that the pre-defined requisites of a procedure or a specific process, which affect the quality and safety of blood and its components, can be systematically fulfilled.

It is to be hoped that correcting the above-reported critical elements of the system, respecting national and European Community dispositions, will lead to the requisites of the transfusion network being adapted to European standards.

The new European regulations on transfusion activities, which originated from the 2002/98/EC Directive of the European Parliament and Council of January 27^th, 2003⁵, set out the need for uniform quality and safety requisites for transfusion products and activities throughout the Community and introduced a series of rigorous and tasking regulations, including those in the subsequent “derivate” Directives^6,11,12. Directive 2002/98/EC was adopted in Italy under DLgs n. 191 of August 19^th, 2005¹⁰ which, because of the need for harmonisation with Law n. 219 of October 21^st, 2005⁴, enacted shortly afterwards, underwent a major revision and was substituted by DLgs n. 261 of December 20^th, 2007¹⁶.

Law 219/2005 is the culmination of a huge amount of analysis⁴, discussion and, above all, sharing of objectives and intentions among all the players involved in the blood system (local and national institutions, associations and federations of voluntary blood donors, and professionals); it outlined not only the present but also the future of Italian transfusion medicine, in terms of the fundamental principles, objectives, areas regulated, requisites and instruments for their application, in accordance with the trends in the more evolved countries of the European Union and with the recommendations of the World Health Organization²³. The re-definition of the minimum requisites for transfusion activities called for in Article 19 of the above-mentioned law, and to be agreed by the State and the Regions, should take into account a very complex set of reference regulations made up of the national and European legislation issued since 2002^4–16.

Furthermore, apart from the specific provision of Article 19 mentioned above⁴ and pre-existing regulations, the national legislation adopting the European Commission directive 2002/98/EC⁵ and its “derivate” directives 2005/61/EC¹¹ and 2005/62/EC¹² - DLgs 261¹⁶, 207¹⁴ and 208¹⁵ of 2007, respectively - has recently introduced new requisites (concerning the quality and safety of blood and blood components, the traceability of the process from donation to transfusion, detection of severe adverse reactions and events and quality systems in Transfusion Services) which must also be included in the “corpus” of minimum requisites that is to be redefined for the purposes of authorisation processes and accreditation in the sector.

The provisions contained in the legislation adopting the European directives must be considered “minimum” requisites, both because all existing regulations on health care activities are considered such, and because the directives are aimed at guaranteeing that European regulations are satisfied throughout the European Community, so that all citizens circulating freely in Europe are ensured homogeneous levels of quality and safety of transfusion-related products and services¹⁸.

It is to be hoped that the review of the authorisation requisites by the State-Region agreement, as set out in Article 19 of Law 219/2005, will redefine the necessary set of requisites in a clear and organic manner¹⁸, facilitating, in particular, their real applicability in order to promote, in compliance with the several reference regulations, an efficient fulfilment of the requisites and, more generally, a sustainable development and widespread diffusion of uniform and transparent quality systems, centred on the objectives of transfusion activities affecting the safety of the donor and patient and directed at continuous improvement of the activities.

Likewise, in accordance with Article 20 of Law 219/2005, guidelines for accreditation will be drawn up by the National Blood Centre¹⁸ after the emanation of the above-mentioned agreement between the State and Regions. With regards to technical requisites, these guidelines should certainly not add further elements to the already substantial and exhaustive series of requisites that will derive from harmonised application of the regulations cited. The guidelines should, however, contain indications aimed at facilitating the widespread application of the regulations, as well as indications aimed at implementing processes of rationalisation of the activities and, not least, precise directions to uniform some fundamental aspects of the procedures and methods of carrying out inspections in the context of regional systems.

Indeed, at present audit and inspection systems in Italy are very varied¹⁸ in that every Region has its own autonomously structured pathways, with very different procedures, team composition and operational methods. Furthermore, most Italian TS (and UDRA) have not undergone any type of verification for a long time, in some cases even since the establishment or authorisation of the institution. This is in clear contrast with the indications of directive 2002/98/EC⁵, adopted under Article 5 of the DLgs 261/2007¹⁶, and is a situation that does not fulfil one of the fundamental principles of the European Community provisions that call for the quality and safety of transfusion systems in the member States to be guaranteed by, among other things, periodic, biannual checks of conformity with the defined requisites.

In this scenario, the activities of UDRA should respond to the logics of rational planning while meeting the minimal requisites, which include the volume of activity of each accredited UDRA, since this is a fundamental element guaranteeing the quality and safety of the blood collected. This guarantee is provided not only by conformity with minimal structural and technological requisites, but also, if not above all, by the presence of professionals with “certificated” skills, maintained over time, who carry out significant volumes of activities in order to guarantee the necessary levels of experience and performance. This is also important with the view of being able to support the now unavoidable impact of a system of structural, organisational and technological requisites that conform with the new norms, without losing the role and contribution of the associations and federations of donors to the mission of the national blood system, which is the very basis of their existence and function.

Generally speaking, the new institutional pathways of authorisation and accreditation offer an important occasion to guarantee a high level of homogeneity, standardisation, efficacy and transparency of transfusion medicine activities, and to ensure an organic fulfilment of the requisites of quality and safety laid out in current legislation and Community norms.

Other important opportunities are the creation of conditions to valorise the many strong points of the Italian transfusion system and the introduction of reorganisation processes aimed at recuperating resources to re-invest in continuous quality and safety improvement and in innovation and development of transfusion medicine. It is to be hoped that these processes preserve, albeit within a context of rationalisation and sustainability, one of the strongest features of the Italian blood system, which is the widespread presence of hospital specialists in transfusion medicine. These specialists guarantee not only the quality and safety of the products and activities of transfusion medicine, but also homogenous levels of care, characterised by appropriate use of blood components and plasma-derived drugs throughout the country²². Furthermore, the definition and guarantees of essential levels of care in the specific setting of transfusion medicine imply a new, more appropriate conception of self-sufficiency, that is, as the result of the productive activities of a network system, which constitutes the essential presupposition to ensure that the quality, safety and appropriateness of the sector of the National Health Service dedicated to transfusion medicine are uniform throughout the country.

In conclusion, the data from the present survey identify decisional and strategic elements useful for redefining minimal structural, technological and organisation requisites, as well as for the National Blood Centre’s formulation of guidelines for accreditation. The survey provides a photograph of the current situation of the Italian transfusion system with regards to certification, accreditation, levels of conformity with current mandatory requisites, professional standards and potential to deliver transfusion medicine health services and shows the critical elements of the national transfusion network which must be tackled in the light of the new authorisation and institutional accreditation processes.

Appendix. Questionaire