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The selection of donors in multicomponent collection management
Transfusion and Apheresis Science 30 (2004) 55–59 www.elsevier.com/locate/transci
The selection of donors in multicomponent collection management Pietro Bonomo a
a,b
, Giovanni Garozzo
a,b,*
, Franco Bennardello
a,b
Immunohaemotological and Transfusional Medicine Service, ‘‘Civile-M.P.Arezzo’’ Hospital, Piazza Igea 1, Ragusa 97100, Italy b AVIS Permanent Collection Center, Via V.E. Orlando 1, Ragusa 97100, Italy Received in revised form 24 April 2003; accepted 28 May 2003
Abstract The use of cell separators in multicomponent collection (MCC) makes it possible to use donors effectively by personalising the donation on the basis of their haemotological and physical profiles and thereby standardising the product. We have applied the selection parameters currently used in our collection centre to 6687 donors using a common software programme for all: 57.6% were eligible for the various forms of MCC, although our parameters are even stricter than those required by law. Between 01 September 2001 and 28 February 2002, 345 MCC (9% of all the donations made) were performed and assessed: 111 donations of double red cell units, 153 donations of red cells and plasma, 62 donations of plasma and platelets, 19 donations of double platelet units: only slight, adverse reactions were encountered in 6% of the procedures. 68 double red cell unit donors and 65 red cell and plasma donors were then reassessed 6 months after MCC: the parameters assessed (hemoglobin, serum iron, ferritin, and total protein) were the same as the pre-donation data. All the units collected complied with legal requirements. With the use of parameters based on donor hematological and physical characteristics we can move from the concept of tailored transfusions to the concept of tailored donations thereby ensuring donor safety and meeting patient needs. 2003 Elsevier Ltd. All rights reserved. Keywords: Blood donors selection; Multicomponent collection
1. Introduction The final quality of blood and haemocomponents depends on various factors and begins with the selection of donors and the type of blood * Corresponding author. Address: Via Monte Amiata 10, Ragusa 97100, Italy. Tel.: +39-932-600002/600000; fax: +39932-227065/600004. E-mail address: [email protected] (G. Garozzo).
collection (Council of Europe Recommendation No. R (95) 15 concerning: preparation, use and guarantee of blood components). This recommendation which now in its seventh edition; indicates donor characteristics in terms of both whole blood, blood components and multicomponents [1]. The parameters for the individual types of donation have also been addressed in the decrees of 25 and 26 January 2001; a few differences between the two pieces of legislation should be pointed out
1473-0502/$ - see front matter 2003 Elsevier Ltd. All rights reserved. doi:10.1016/j.transci.2003.05.001
56
P. Bonomo et al. / Transfusion and Apheresis Science 30 (2004) 55–59
(to these are the advantage of the donor and the recipient receiver) [2,3]. Italian legislation (law 107/90) shows which activities must be carried out in transfusion facilities [4], but not all transfusion centres can carry out all of the activities mainly because of problems related to economy-of-scale which translate into problems of efficiency and efficacy. From this point of view, the production activities which are to be centralised are indicated (for example, the performance of the NAT) as are those to be shunted off to the periphery (donor selection, blood collection in all its various forms). To this end, in article 7, law 107/90 provides for the possibility collecting blood by permanent and mobile collection centres managed by non-remunerated volunteer associations (who are, however, answerable to the reference Immunohaematological and Transfusion Medicine Service (ITMS) from the technical and organisational point of view); furthermore ‘‘associated collection (based on nonremunerated volunteers, editor’s note), where regional programming is required, can constitute, if managed efficiently, an element of flexibility in the system’’ (National Blood and Plasma Scheme [Piano Nazionale Sangue e Plasma] 1999–2001) [5].
2. Materials and methods 6468 units of blood were collected at the AVIS (Italian Blood Volunteers Association) Permanent
Collection Centre (PCC) and certified ISO 9000 in Ragusa between 01 September 2001 and 28 February 2002. Of these MCC accounted for 5.3% with the remainder being donations of whole blood (67.2%), plasma (25.7%), and platelets (1.8%). The MCC broke down as follows: 111 (1.7% of the total) double concentrated red cell units (R– R), 153 (2.4%) concentrated red cell and plasma units (R–P), 62 (0.9%) plasma and platelet units (P–PLT) and 19 (0.3%) of double platelet units (2PLT). Units of RBC/PLT are not collected at our centre as there is neither a specific necessity nor demand. The automatic collection of haemocomponents can allow existing donors to be used in the most effective way by personalising the donation on the basis of their physical and haemotological characteristics thus enhancing blood product uniformity to their standardisation (see Table 1) [6,7]. At the AVIS-ITMS PCC we applied these characteristics to the data base of the donors using a common commercially available program (ACCESS Microsofte). The results of this selection are shown in Table 2. The use of selection criteria that are stricter than those required by law [3], made it possible to identify 3851 potential MCC donors (57.6%). To assess the adverse reactions to MCC, donations made in the same period were analysed. There were 345 MCCs out of the 3851 eligible donors (9%) using four MCS+ separators (Haemonetics Corporation, Baintree, MA).
Table 1 Haemotological characteristics for the personalisation of the donation currently adopted at the ITMS in Ragusa (latest revision dated February 2002) Blood and clinical characteristics
Recommended donation
PLT > 200.000 < 299.000, Hb > 11.5 < 14.4, total proteins > 6.0 < 8.5 g/dl, weight > 60 kg PLT > 200.000 < 299.000, Hb > 11.5 < 14.4, total proteins > 6.0 < 8.5 g/dl, weight < 60 kg PLT > 200.000 < 299.000, Hb > 14.5 < 15.4, ferritin > 20 ng/ml, weight > 60 kg PLT > 300.000, Ht < 40%, weight > 60 kg PLT < 200.000, Hb > 14.5 < 15.5, ferritin > 20 ng/ml, total proteins > 6.0 < 8.5, weight > 60 kg Hb > 15.5, ferritin > 50 ng/ml, weight > 70 kg Female donors: Hb > 12.5 < 13.5, total proteins > 6.0 < 8.5 Male donors: Hb > 13.5 < 14.5, total proteins > 6.0 < 8.5 Thalasemic trait, total proteins > 6.0 < 8.5 Group AB, Ht < 45%, total proteins > 6.0 < 8.5
P–PLT PLT P R–PLT WB 2PLT R–P WB R–R P WB alternating with P P P
Plasmaplatelet apheresis (P–PLT), platelet apheresis (PLT), plasma apheresis (P), erythroplatelet apheresis (R–PLT), whole blood (WB), double platelet apheresis (2PLT), erythroplasma apheresis (R–P), double concentrated red cell units (R–R).
P. Bonomo et al. / Transfusion and Apheresis Science 30 (2004) 55–59
57
Table 2 Donors assessed according to Table 1 parameters and using the data present in the Permanent Collection Centre data base distinguishing by sex and by type of MCC (see Table 1 for the legend) Donors
Total
Males
Females
Donors assessed for multicomponent collection (MCC) from 01.09.2001 to 28.02.2002 Assessed 6687 4394 (65.7%) Clinically eligible 3851 (57.6%) 3017 (78.3%)
2293 (34.7%) 834 (21.7%)
Theoretically eligible for the different procedures Type of donation Total donors R–R R–P P–PLT 2PLT R–PLT
457/3851 (11.8%) 274/3851 (7.1%) 1286/3851 (33.4%) 754/3851 (19.6%) 1080/3851 (28.1%)
Table 3 shows the donations carried out which are distinguished by type and by sex of donors. The chance of choosing was given to donors who were eligible for more than one form of blood donation: in Ragusa the ratio of inhabitants/donors is 12.5%, the production of plasma corresponds to 183% of requirements defined by the World Health Organisation; 29% of the units collected are given to other transfusion centres. The incidence of reactions to the donations is shown in Table 4. To assess the haemotological alterations caused in donors of double concentrated red cell units
457/3017 (15.1%) 255/3017 (8.4%) 723/3017 (23.9%) 523/3017 (17.3%) 1026/3017 (34.0%)
0/834 (0.0%) 0/834 (0.0%) 567/834 (68%) 225/834 (27%) 34/834 (4%)
(R–R) and in donors of concentrated red cell and plasma (R–P), 68 R–R donors and 65 R–P donors that made a second donation (of any type) 6 months after the MCC were analysed in the period under consideration and that did not make any donation in the period between these two donations. The parameters compared for the R–R were: haemoglobin, serum iron, ferritin and for R–P: haemoglobin, serum iron, ferritin, total proteins. The results have been shown in Table 5. To assess the quality of the units collected they were checked as per European Recommendation
Table 3 MCCs carried out from 01.09.2001 to 28.02.2002 broken down by sex and by donation type (see Table 1 for the legend) Total MCCs carried out: distinguished by sex and by type Donors 345/3851 (9%) Donation type
Total donors
R–R R–P P–PLT 2PLT
111/345 (32%) 153/345 (44%) 62/345 (18%) 19/345 (5.5%)
Males
Females
264/3017 (8.8%)
94/834 (11.3%)
111/111 (100%) 153/153 (100%) 0/0 (0%) 0/0 (0%)
0/0 (0%) 0/0 (0%) 62/62 (100%) 19/19 (100%)
Table 4 Types of reaction in 345 MCCs and length of the procedure broken down by type (see Table 1 for the legend) Vagal
Syncope
Type of reactions and average duration of the donations R–R 1/111 (0.9%) 0/111 R–P 1/153 (0.65%) 1/153 (0.65%) P–PLT 1/62 (1.6%) 0/62 2PLT 0/19 0/19
Tingling
Tetany
Duration (min)
1/111 (0.9%) 1/153 (0.65%) 13/62 (20.9%) 1/19 (5.2%)
0/111 0/153 0/62 0/19
39 38 64 70
58
P. Bonomo et al. / Transfusion and Apheresis Science 30 (2004) 55–59
Table 5 Checked haematochemical parameters six months from the MCC (see Table 1 for the legend) Hb (g/dl) Pre
Iron serum Post
Follow up of the R–R and R–P donors R–R 15.97 15.81 R–P 15.3 15.5
Ferritin
Total proteins
Pre
Post
Pre
Post
Pre
Post
93 94
96 105
85 73
67 70
– 7.2
– 7.1
Table 6 The quality checks performed on the MCC collected units Quality control Haematocryt Haemoglobin Platelets Residual leukocytes Factor VIII
R–R
R–P
P–PLT
2PLT
59.2 106.2 – 0.26 –
56.4 59.4 – 0.89 0.9
– – 3.7 0.06 0.9
– – 6.1 0.08 –
The reference values are haematocryt: between 50% and 70% for both R–R and R–P; haemoglobin: >90 g/unit for R–R and >45 g/unit for R–P; platelets: >2 · 1011 for P–PLT and >4 · 1011 for 2PLT; residual leukocytes before leukodepletion: <1 · 109 for all the haemocomponents; factor VIII: >0.7 UI/ml (for the legend see Table 1).
No. R(95)15, seventh edition, [1] and Ministerial Decree 25 January 2001 [2]. The results of the checks have been shown in Table 6.
3. Quality checks: the products obtained from the MCC complied with the reference parameters and current legal requirements fully.
3. Results
4. Comments
1. Adverse events: the presence of reactions such as tingling must be read in relation to the type of donation and its length. In fact, as shown in Table 4 the longer the donation the greater the quantity of ACD administered and therefore a greater possibility of a reaction might occur: at our PCC calcium was not administered by injection preventively (as this was not considered to be ethically correct) and therefore there is a high incidence of tingling. With the use of the new versions of software made available by the separator manufacturer, it is thought that this reaction will become less and less common. 2. Donor follow up: as can be seen in Table 5, after 6 months the haematochemical parameters considered have not shown a substantial difference between pre- and post-donation. These figures show the safety for the donor provided by MCC [6].
The implementation of a new donor selection philosophy and therefore the MCC entails a cultural revolution that underlies a new haemotological approach in the enlisting of donors and therefore a reorganisation of the donor field [7], an adequate training of the health and administrative staff following the purchase of cell separators and the new call methods, a compliance of the nonremunerated volunteerÕs association and the donors themselves, the acquisition of new technologies (management networks, use of barcodes to identify: staff, donors, expendible material etc.) for the better management of these changes and for the achievement of quality in blood collection. Only an integration of public (ITMS) and private (non-remunerated donor associations) sectors, can lead to mutual advantage. Undoubtedly there has been an evolution in the concepts governing the transfusion world passing from the concept of tailored transfusion to tailored donation
P. Bonomo et al. / Transfusion and Apheresis Science 30 (2004) 55–59
and therefore to that of personalised donation: in the first place the donor association will have to ensure the well-being of the donor and then the ITMSs plasma, platelets, double red cell requirement and have client donor satisfaction as an aim [7]. For this reason MCC can obtain self sufficiency while also maintaining donor safety, which is guaranteed by the fact that the donation is tailored on his physical and haematochemical characteristics [8,9]. The use of MCC techniques, such as the donation of plasma and platelets or the donation of double red cells, if performed on donors with the characteristics shown in Table 1, has made possible to keep the number of collected units where we work equal to those of the previous year despite the fall in the number of donors.
5. Conclusions 1. MCC must be at the centre of a common effort of all the actors in the system (donors, associations, transfusional services). 2. The potential of MCC donation has not yet been fully expressed because only 9% of the donors who can make an MCC donation have actually done so. 3. The programming of the collection must concern both its quality and its quantity. 4. It is necessary to have proper training and refresher courses for the personnel. 5. The implementation of a quality system in the collection field is fundamental to allow all the actors (Associations, Transfusional Services and Suppliers) to achieve ongoing improvements with the safety and guarantee of the donor as its aim.
59
Acknowledgements We would like to thank all the donors of AVIS for their generosity, the doctors in the Immunohaemotology and Transfusional Medicine Service and all the doctors, nurses and administrative staff of the AVIS PCC in Ragusa for the patience they treat us with everyday.
References [1] Guide to the preparation, use and quality assurance of blood components. seventh edition. Strabourg: Council of Europe Publishing; 2001. [2] Ministry of Health: Decree 25 January 2001 (Official Gazette General Series no. 78, 3 April 2001): Characterisitics and methods of blood and blood component donation. [3] Ministry of Health: Decree 26 January 2001 (Official Gazette General Series no. 78, 3 April 2001): Protocols for the assessment of blood and blood component donor suitability. [4] Law no. 107 dated 4 May 1990 (Official Gazette General Series no. 108, 11 May 1990): Regulations for transfusion operations regarding human blood and its components and for the production of plasma derivatives. [5] National Blood and Plasma Scheme, 1999–2001. [6] Bonomo P, Distefano R, Garozzo G, et al. Donation of double concentrated red cell units by single donor using MCS Plus cell separator. La Trasfusione del Sangue 1998;43:228. [7] Garozzo G, Raniolo F, Dimartino G, Bonomo P. Illustration of a questionnaire aimed at the assessment of blood donor satisfaction. La Trasfusione del Sangue 2001;46:232. [8] Bonomo P. The quality and selection of the donors and procedures for taking blood can contribute to the achievement of self sufficiency without wasting resources. AVIS SOS 1997;(June):15. [9] Bonomo P. Diversification in donation: a new calibrated approach on the haemotological characteristics of the donor and on the maximum transfusional yield for the patient. In: Proceedings of the SIMTI Interregional convention: Transfusional safety: from donor to patient’’, Torino, 1999 (April), pp. 28–30.
The selection of donors in multicomponent collection management Pietro Bonomo a
a,b
, Giovanni Garozzo
a,b,*
, Franco Bennardello
a,b
Immunohaemotological and Transfusional Medicine Service, ‘‘Civile-M.P.Arezzo’’ Hospital, Piazza Igea 1, Ragusa 97100, Italy b AVIS Permanent Collection Center, Via V.E. Orlando 1, Ragusa 97100, Italy Received in revised form 24 April 2003; accepted 28 May 2003
Abstract The use of cell separators in multicomponent collection (MCC) makes it possible to use donors effectively by personalising the donation on the basis of their haemotological and physical profiles and thereby standardising the product. We have applied the selection parameters currently used in our collection centre to 6687 donors using a common software programme for all: 57.6% were eligible for the various forms of MCC, although our parameters are even stricter than those required by law. Between 01 September 2001 and 28 February 2002, 345 MCC (9% of all the donations made) were performed and assessed: 111 donations of double red cell units, 153 donations of red cells and plasma, 62 donations of plasma and platelets, 19 donations of double platelet units: only slight, adverse reactions were encountered in 6% of the procedures. 68 double red cell unit donors and 65 red cell and plasma donors were then reassessed 6 months after MCC: the parameters assessed (hemoglobin, serum iron, ferritin, and total protein) were the same as the pre-donation data. All the units collected complied with legal requirements. With the use of parameters based on donor hematological and physical characteristics we can move from the concept of tailored transfusions to the concept of tailored donations thereby ensuring donor safety and meeting patient needs. 2003 Elsevier Ltd. All rights reserved. Keywords: Blood donors selection; Multicomponent collection
1. Introduction The final quality of blood and haemocomponents depends on various factors and begins with the selection of donors and the type of blood * Corresponding author. Address: Via Monte Amiata 10, Ragusa 97100, Italy. Tel.: +39-932-600002/600000; fax: +39932-227065/600004. E-mail address: [email protected] (G. Garozzo).
collection (Council of Europe Recommendation No. R (95) 15 concerning: preparation, use and guarantee of blood components). This recommendation which now in its seventh edition; indicates donor characteristics in terms of both whole blood, blood components and multicomponents [1]. The parameters for the individual types of donation have also been addressed in the decrees of 25 and 26 January 2001; a few differences between the two pieces of legislation should be pointed out
1473-0502/$ - see front matter 2003 Elsevier Ltd. All rights reserved. doi:10.1016/j.transci.2003.05.001
56
P. Bonomo et al. / Transfusion and Apheresis Science 30 (2004) 55–59
(to these are the advantage of the donor and the recipient receiver) [2,3]. Italian legislation (law 107/90) shows which activities must be carried out in transfusion facilities [4], but not all transfusion centres can carry out all of the activities mainly because of problems related to economy-of-scale which translate into problems of efficiency and efficacy. From this point of view, the production activities which are to be centralised are indicated (for example, the performance of the NAT) as are those to be shunted off to the periphery (donor selection, blood collection in all its various forms). To this end, in article 7, law 107/90 provides for the possibility collecting blood by permanent and mobile collection centres managed by non-remunerated volunteer associations (who are, however, answerable to the reference Immunohaematological and Transfusion Medicine Service (ITMS) from the technical and organisational point of view); furthermore ‘‘associated collection (based on nonremunerated volunteers, editor’s note), where regional programming is required, can constitute, if managed efficiently, an element of flexibility in the system’’ (National Blood and Plasma Scheme [Piano Nazionale Sangue e Plasma] 1999–2001) [5].
2. Materials and methods 6468 units of blood were collected at the AVIS (Italian Blood Volunteers Association) Permanent
Collection Centre (PCC) and certified ISO 9000 in Ragusa between 01 September 2001 and 28 February 2002. Of these MCC accounted for 5.3% with the remainder being donations of whole blood (67.2%), plasma (25.7%), and platelets (1.8%). The MCC broke down as follows: 111 (1.7% of the total) double concentrated red cell units (R– R), 153 (2.4%) concentrated red cell and plasma units (R–P), 62 (0.9%) plasma and platelet units (P–PLT) and 19 (0.3%) of double platelet units (2PLT). Units of RBC/PLT are not collected at our centre as there is neither a specific necessity nor demand. The automatic collection of haemocomponents can allow existing donors to be used in the most effective way by personalising the donation on the basis of their physical and haemotological characteristics thus enhancing blood product uniformity to their standardisation (see Table 1) [6,7]. At the AVIS-ITMS PCC we applied these characteristics to the data base of the donors using a common commercially available program (ACCESS Microsofte). The results of this selection are shown in Table 2. The use of selection criteria that are stricter than those required by law [3], made it possible to identify 3851 potential MCC donors (57.6%). To assess the adverse reactions to MCC, donations made in the same period were analysed. There were 345 MCCs out of the 3851 eligible donors (9%) using four MCS+ separators (Haemonetics Corporation, Baintree, MA).
Table 1 Haemotological characteristics for the personalisation of the donation currently adopted at the ITMS in Ragusa (latest revision dated February 2002) Blood and clinical characteristics
Recommended donation
PLT > 200.000 < 299.000, Hb > 11.5 < 14.4, total proteins > 6.0 < 8.5 g/dl, weight > 60 kg PLT > 200.000 < 299.000, Hb > 11.5 < 14.4, total proteins > 6.0 < 8.5 g/dl, weight < 60 kg PLT > 200.000 < 299.000, Hb > 14.5 < 15.4, ferritin > 20 ng/ml, weight > 60 kg PLT > 300.000, Ht < 40%, weight > 60 kg PLT < 200.000, Hb > 14.5 < 15.5, ferritin > 20 ng/ml, total proteins > 6.0 < 8.5, weight > 60 kg Hb > 15.5, ferritin > 50 ng/ml, weight > 70 kg Female donors: Hb > 12.5 < 13.5, total proteins > 6.0 < 8.5 Male donors: Hb > 13.5 < 14.5, total proteins > 6.0 < 8.5 Thalasemic trait, total proteins > 6.0 < 8.5 Group AB, Ht < 45%, total proteins > 6.0 < 8.5
P–PLT PLT P R–PLT WB 2PLT R–P WB R–R P WB alternating with P P P
Plasmaplatelet apheresis (P–PLT), platelet apheresis (PLT), plasma apheresis (P), erythroplatelet apheresis (R–PLT), whole blood (WB), double platelet apheresis (2PLT), erythroplasma apheresis (R–P), double concentrated red cell units (R–R).
P. Bonomo et al. / Transfusion and Apheresis Science 30 (2004) 55–59
57
Table 2 Donors assessed according to Table 1 parameters and using the data present in the Permanent Collection Centre data base distinguishing by sex and by type of MCC (see Table 1 for the legend) Donors
Total
Males
Females
Donors assessed for multicomponent collection (MCC) from 01.09.2001 to 28.02.2002 Assessed 6687 4394 (65.7%) Clinically eligible 3851 (57.6%) 3017 (78.3%)
2293 (34.7%) 834 (21.7%)
Theoretically eligible for the different procedures Type of donation Total donors R–R R–P P–PLT 2PLT R–PLT
457/3851 (11.8%) 274/3851 (7.1%) 1286/3851 (33.4%) 754/3851 (19.6%) 1080/3851 (28.1%)
Table 3 shows the donations carried out which are distinguished by type and by sex of donors. The chance of choosing was given to donors who were eligible for more than one form of blood donation: in Ragusa the ratio of inhabitants/donors is 12.5%, the production of plasma corresponds to 183% of requirements defined by the World Health Organisation; 29% of the units collected are given to other transfusion centres. The incidence of reactions to the donations is shown in Table 4. To assess the haemotological alterations caused in donors of double concentrated red cell units
457/3017 (15.1%) 255/3017 (8.4%) 723/3017 (23.9%) 523/3017 (17.3%) 1026/3017 (34.0%)
0/834 (0.0%) 0/834 (0.0%) 567/834 (68%) 225/834 (27%) 34/834 (4%)
(R–R) and in donors of concentrated red cell and plasma (R–P), 68 R–R donors and 65 R–P donors that made a second donation (of any type) 6 months after the MCC were analysed in the period under consideration and that did not make any donation in the period between these two donations. The parameters compared for the R–R were: haemoglobin, serum iron, ferritin and for R–P: haemoglobin, serum iron, ferritin, total proteins. The results have been shown in Table 5. To assess the quality of the units collected they were checked as per European Recommendation
Table 3 MCCs carried out from 01.09.2001 to 28.02.2002 broken down by sex and by donation type (see Table 1 for the legend) Total MCCs carried out: distinguished by sex and by type Donors 345/3851 (9%) Donation type
Total donors
R–R R–P P–PLT 2PLT
111/345 (32%) 153/345 (44%) 62/345 (18%) 19/345 (5.5%)
Males
Females
264/3017 (8.8%)
94/834 (11.3%)
111/111 (100%) 153/153 (100%) 0/0 (0%) 0/0 (0%)
0/0 (0%) 0/0 (0%) 62/62 (100%) 19/19 (100%)
Table 4 Types of reaction in 345 MCCs and length of the procedure broken down by type (see Table 1 for the legend) Vagal
Syncope
Type of reactions and average duration of the donations R–R 1/111 (0.9%) 0/111 R–P 1/153 (0.65%) 1/153 (0.65%) P–PLT 1/62 (1.6%) 0/62 2PLT 0/19 0/19
Tingling
Tetany
Duration (min)
1/111 (0.9%) 1/153 (0.65%) 13/62 (20.9%) 1/19 (5.2%)
0/111 0/153 0/62 0/19
39 38 64 70
58
P. Bonomo et al. / Transfusion and Apheresis Science 30 (2004) 55–59
Table 5 Checked haematochemical parameters six months from the MCC (see Table 1 for the legend) Hb (g/dl) Pre
Iron serum Post
Follow up of the R–R and R–P donors R–R 15.97 15.81 R–P 15.3 15.5
Ferritin
Total proteins
Pre
Post
Pre
Post
Pre
Post
93 94
96 105
85 73
67 70
– 7.2
– 7.1
Table 6 The quality checks performed on the MCC collected units Quality control Haematocryt Haemoglobin Platelets Residual leukocytes Factor VIII
R–R
R–P
P–PLT
2PLT
59.2 106.2 – 0.26 –
56.4 59.4 – 0.89 0.9
– – 3.7 0.06 0.9
– – 6.1 0.08 –
The reference values are haematocryt: between 50% and 70% for both R–R and R–P; haemoglobin: >90 g/unit for R–R and >45 g/unit for R–P; platelets: >2 · 1011 for P–PLT and >4 · 1011 for 2PLT; residual leukocytes before leukodepletion: <1 · 109 for all the haemocomponents; factor VIII: >0.7 UI/ml (for the legend see Table 1).
No. R(95)15, seventh edition, [1] and Ministerial Decree 25 January 2001 [2]. The results of the checks have been shown in Table 6.
3. Quality checks: the products obtained from the MCC complied with the reference parameters and current legal requirements fully.
3. Results
4. Comments
1. Adverse events: the presence of reactions such as tingling must be read in relation to the type of donation and its length. In fact, as shown in Table 4 the longer the donation the greater the quantity of ACD administered and therefore a greater possibility of a reaction might occur: at our PCC calcium was not administered by injection preventively (as this was not considered to be ethically correct) and therefore there is a high incidence of tingling. With the use of the new versions of software made available by the separator manufacturer, it is thought that this reaction will become less and less common. 2. Donor follow up: as can be seen in Table 5, after 6 months the haematochemical parameters considered have not shown a substantial difference between pre- and post-donation. These figures show the safety for the donor provided by MCC [6].
The implementation of a new donor selection philosophy and therefore the MCC entails a cultural revolution that underlies a new haemotological approach in the enlisting of donors and therefore a reorganisation of the donor field [7], an adequate training of the health and administrative staff following the purchase of cell separators and the new call methods, a compliance of the nonremunerated volunteerÕs association and the donors themselves, the acquisition of new technologies (management networks, use of barcodes to identify: staff, donors, expendible material etc.) for the better management of these changes and for the achievement of quality in blood collection. Only an integration of public (ITMS) and private (non-remunerated donor associations) sectors, can lead to mutual advantage. Undoubtedly there has been an evolution in the concepts governing the transfusion world passing from the concept of tailored transfusion to tailored donation
P. Bonomo et al. / Transfusion and Apheresis Science 30 (2004) 55–59
and therefore to that of personalised donation: in the first place the donor association will have to ensure the well-being of the donor and then the ITMSs plasma, platelets, double red cell requirement and have client donor satisfaction as an aim [7]. For this reason MCC can obtain self sufficiency while also maintaining donor safety, which is guaranteed by the fact that the donation is tailored on his physical and haematochemical characteristics [8,9]. The use of MCC techniques, such as the donation of plasma and platelets or the donation of double red cells, if performed on donors with the characteristics shown in Table 1, has made possible to keep the number of collected units where we work equal to those of the previous year despite the fall in the number of donors.
5. Conclusions 1. MCC must be at the centre of a common effort of all the actors in the system (donors, associations, transfusional services). 2. The potential of MCC donation has not yet been fully expressed because only 9% of the donors who can make an MCC donation have actually done so. 3. The programming of the collection must concern both its quality and its quantity. 4. It is necessary to have proper training and refresher courses for the personnel. 5. The implementation of a quality system in the collection field is fundamental to allow all the actors (Associations, Transfusional Services and Suppliers) to achieve ongoing improvements with the safety and guarantee of the donor as its aim.
59
Acknowledgements We would like to thank all the donors of AVIS for their generosity, the doctors in the Immunohaemotology and Transfusional Medicine Service and all the doctors, nurses and administrative staff of the AVIS PCC in Ragusa for the patience they treat us with everyday.
References [1] Guide to the preparation, use and quality assurance of blood components. seventh edition. Strabourg: Council of Europe Publishing; 2001. [2] Ministry of Health: Decree 25 January 2001 (Official Gazette General Series no. 78, 3 April 2001): Characterisitics and methods of blood and blood component donation. [3] Ministry of Health: Decree 26 January 2001 (Official Gazette General Series no. 78, 3 April 2001): Protocols for the assessment of blood and blood component donor suitability. [4] Law no. 107 dated 4 May 1990 (Official Gazette General Series no. 108, 11 May 1990): Regulations for transfusion operations regarding human blood and its components and for the production of plasma derivatives. [5] National Blood and Plasma Scheme, 1999–2001. [6] Bonomo P, Distefano R, Garozzo G, et al. Donation of double concentrated red cell units by single donor using MCS Plus cell separator. La Trasfusione del Sangue 1998;43:228. [7] Garozzo G, Raniolo F, Dimartino G, Bonomo P. Illustration of a questionnaire aimed at the assessment of blood donor satisfaction. La Trasfusione del Sangue 2001;46:232. [8] Bonomo P. The quality and selection of the donors and procedures for taking blood can contribute to the achievement of self sufficiency without wasting resources. AVIS SOS 1997;(June):15. [9] Bonomo P. Diversification in donation: a new calibrated approach on the haemotological characteristics of the donor and on the maximum transfusional yield for the patient. In: Proceedings of the SIMTI Interregional convention: Transfusional safety: from donor to patient’’, Torino, 1999 (April), pp. 28–30.