Inventory Management - Wiley Online Library

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on inventory management, e.g. blood substitutes, pathogen inactivation ...... w.nussi@mac.com ... software. Our inventory level is being placed on a level of 5 days inventory and for O+, O) and A) it's a 7 days inventory. ..... business continuity.
Vox Sanguinis (2010) 98: e295–e363

INTERNATIONAL FORUM

ª 2009 The Author(s) Journal compilation ª 2009 International Society of Blood Transfusion DOI: 10.1111/j.1423-0410.2009.1252.x

Inventory Management D. V. Devine, G. D. Sher, H. W. Reesink, S. Panzer, P. A. S. Hetzel, J. K. Wong, M. Horvath, G. C. Leitner, H. Schennach, W. Nussbaumer, K. Genoe, J. M. Cioffi, F. N. Givisiez, M. Rogerson, D. Howe, G. Delage, C. Sarappa, Y. Charbonneau, Y. Fu, D. Šarlija, T. Vuk, M. Strauss Patko, M. Balija, I. Jukic´, A. Ali, M.-K. Auvinen, E. Jaakonsalo, J.-P. Cazenave, C. Waller, D. Kientz, B. David, G. Walther-Wenke, M. Heiden, C. K. Lin, W. C. Tsoi, C. K. Lee, K. Barotine-Toth, R. B. Sawant, W. Murphy, B. Quirke, P. Bowler, E. Shinar, V. Yahalom, G. Aprili, P. Piccoli, G. Gandini, K. Tadokoro, V. S. Nadarajan, W. de Kort, N. Jansen, P. Flanagan, P.-O. Forsberg, T. Hervig, M. Letowska, E. Lachert, K. Dudziak, J. Antoniewicz-Papis, G. de Olim, F. Nascimento, S. Hindawi, D. Teo, R. Reddy, J. Scholtz, R. Swanevelder, L. P. Rovira, S. Sauleda, M. A. V. Carasa, M. P. Vaquero, M. A. Ania, H. Gulliksson, S. Holdsworth, S. Cotton, C. Howell, C. Baldwin, R. M. Cusick, G. A. Geele, C. Paden, P. McEvoy, J. L. Gottschall, L. S. McLaughlin, R. J. Benjamin, A. Eder, N. L. Draper, J. P. AuBuchon & G. León de González A critical aspect of blood transfusion is the timely provision of high quality blood products. This task remains a significant challenge for many blood services and blood systems reflecting the difficulty of balancing the recruitment of sufficient donors, the optimal utilization of the donor’s gift, the increasing safety related restrictions on blood donation, a growing menu of specialized blood products and an ever growing imperative to increase the efficiency of blood product provision from a cost perspective. As our industry now faces questions about our standard practices including whether or not the age of blood has a negative impact on recipients, it is timely to take a look at our collective inventory management practices. This International Forum represents an effort to get a snap shot of inventory management practices around the world, and to understand the range of different products provided for patients. In addition to sharing current inventory management practices, this Forum is intended to foster an exchange of ideas around where we see our field moving with respect to various issues including specialty products, new technologies, and reducing recipient risk from blood transfusion products. The following questions were asked of the respondents:

• For the data sets please include not only the most recent year’s data, but also any year-to-year trend data that you can provide.

Question 2 Do you provide specialized products for specific patient populations such as pathogen inactivated products, ‘fresh’ blood products, CMV-negative products, irradiated products, etc.? For which patient groups are these provided? Are you considering the introduction of any new specialized products?

Question 3 What specific inventory management practices, by product, are used in your organization? For example, these may include ‘first-in-last-out’, ‘first-in-first-out’, etc. Are inventory levels managed in an integrated fashion between the blood component producer and the hospital user or managed separately? What are the target inventory levels of each blood product in the overall management structure?

Question 4 Question 1 Please describe the overall structure of your country’s blood system. • Is it managed using a centralized or a decentralized model? • Is inventory moved from one geographic region to another? • What is the shelf life of the different blood products that your system produces? • How many units of each type of product are collected annually, expressed as units per 1000 population? • If known, what is the utilization rate of each product per 1000 population? Please describe how you define ‘utilization’ in this calculation. • What are the outdate rates for each of these products at your centre and at the hospital, if known?

What is the average age of red-blood-cells by blood group at the time of transfusion? Is there a concern in your jurisdiction over the increasing attention being paid to the age of red-blood-cells at transfusion and the possible impact on recipients? If sufficient data were to appear that definitively show that younger red-blood-cells are better for patients, how would this affect your inventory management practices?

Question 5 What is the average age of platelet concentrates at the time of transfusion? Please provide separate data for whole blood derived platelets and apheresis platelets. Is there consideration being given in your jurisdiction for extending the shelf life of platelets?

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If so, what is the rationale and will additional processes to ensure platelet quality be required? If your jurisdiction has undergone a change in platelet shelf life, what impact did that have on the management of platelet inventory?

Question 6 What technologies have been considered by your organization that could have an impact, either positive or negative, on inventory management, e.g. blood substitutes, pathogen inactivation, platelet additive solutions, etc.? We have received responses from 37 organizations representing 30 countries on six continents. Cumulatively, these respondents collect over 30 million components of blood annually. Respondents represent a variety of blood systems, and a variety of types of institutions, from large centralized single-provider national systems to smaller regional hospital based blood services. There are some common approaches to inventory management that can be found among the respondents. All respondents reflect a concern for the value of the blood products, not only in terms of their cost, but also in terms of their relative scarcity. In this light, the almost universally reported inventory management strategy is the ‘first in, first out’ practice which is applied to minimize wastage. The theme of product value also can be seen in the expression of the important role that inventory management plays in the stewardship of blood. Most respondents have activities in place to reduce the discard rates of products. A strong recurring theme in these responses is the presence of gaps in the information required to really have an optimal inventory management system. Many providers of blood products have only one end of the rope: that which is attached to the inventory around the production and distribution processes. Very few respondents had information back from the hospital customers as to the disposition of the products provided in terms of when or even if they were transfused. This lack of information hampers the ability to drive down the rate of avoidable discards or to know if the manner in which the blood provider manages inventory is optimal for patient safety or ready access to transfusion products. With regard to specialized products, in most countries ⁄ centres all cell concentrates are leucocyte-depleted, but in some depleted concentrates are still only provided for certain categories of patients. Irradiated components are available everywhere. It is of interest that in Japan all cell concentrates are irradiated because of the high risk of transfusion-associated GVHD, because of a high percentage of HLA-homozygous subjects in the Japanese population. In most countries CMV-negative products are provided but in some leucocyte-depleted cell concentrates are considered to be safe. In nearly all countries RBCs not older than

3–5 days are provided, mainly for pediatric transfusions. Washed red cells or platelets are mentioned as specialized products by many countries ⁄ centres, indicated for patients who suffered a severe anaphylactic reaction after previous transfusions and for patients with anti-IgA. For the latter, IgA-deficient donors are available in some countries, e.g. in the USA. The provision of HLA-class-I compatible platelets for immunized patients is mentioned in the answers from several countries. For further information about specialized products the reader is referred to the answers. The age of blood components varied considerably among various countries. Respondents expressed a general concern over the issue of the allowable storage of components. In only a few countries ⁄ centres has the storage time of platelet concentrates (PCs) been extended from 5 to 7 days after bacterial testing was implemented. There is still concern about the efficacy of bacterial testing and the quality of platelets stored longer than 5 days. However, some countries indicate that a 7-day storage time will be adopted when pathogen inactivation of PCs is implemented. In most countries ⁄ centres no extension of the storage time is planned, either because there is no logistic need for it or because of the above concerns. With respect to the issue of the age of red-blood-cells, most respondents are concerned about this topic and recognize the increasing scrutiny that this aspect of transfusion medicine is receiving at this time. The general lack of a body of good evidence to support a shortened shelf life for red-blood-cells has caused most respondents to take a position of watchful waiting. However, many respondents are already providing younger red cells for use in pediatric patients. One may observe from the details provided in the responses below, that the view of risk and the factors influencing risk based decision-making are not consistent around the world. Various risk reduction measures are available to transfusion medicine, and it is evident from the varied responses that risk is balanced in different ways in different blood systems. There is necessary consideration of the cost-benefit ratio of risk reduction technologies and practices, and one can see different lines of thinking at play in the choices made by blood systems around risk reduction, particularly for the application of the more expensive technologies such as leucoreduction and pathogen inactivation. It is clear that much change to improve the products that we have for patients is already underway or coming soon. Pathogen reduction ⁄ inactivation was mentioned by many respondents as a process that they intend to implement when technologies are ready, or have recently implemented for platelets or plasma as processes become licensed in their jurisdictions. This technology has already spread widely and will continue to spread further.

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The information exchange implicit in the publication of an International Forum on Inventory Management is only a first step. While there is clearly no singular right way to handle inventory management and the choices involved therein, there is a need for constructive dialogue amongst blood suppliers and users of blood products to identify a set of best ⁄ better practices that can be implemented without prohibitory levels of cost or complexity to increase the availability, safety and quality of blood products for the patients who need them while at the same time increasing the efficiency of this important aspect of blood transfusion management. Guest Editors D. V. Devine Canadian Blood Services Vancouver Canada E-mail: [email protected] G. D. Sher Canadian Blood Services Ottawa Canada E-mail: [email protected] International Forum Editors H. W. Reesink Department of Gastroenterology and Hepatology Academic Medical Center Amsterdam, the Netherlands E-mails: [email protected] [email protected] S. Panzer University of Vienna Wa¨hringer Gu¨rtel 18-20 A-1090 Vienna, Austria E-mails: [email protected] [email protected]

P. A. S. Hetzel & J. K. Wong Question 1 Australia has a national blood system which is fully funded by federal and state and territory governments and delivered by the Australian Red Cross Blood Service which is a national organization and operating division of the Australian Red Cross. All blood products are provided to Australian patients free of charge, and in most instances without a price indicator for the prescriber which may be relevant to differences noted in utilization of some products compared with other countries. The population is growing by natural increases and net immigration by around 1Æ5% per year in recent years.

Inventory within ARCBS is managed nationally and transferred from one geographic region to another to optimize inventory management and to meet clinical need. The shelf life of the different blood products supplied is as follows Whole Blood Red Cells Platelets Clinical FFP Cryoprecipitate Cryodepleted plasma Plasma for fractionation

24 h 42 days 5 days 12 months 12 months 12 months 12 months

For the 2008 ⁄ 2009 financial year, planned collection rates are: Whole Blood Red Cells Platelets Clinical FFP Cryoprecipitate Cryodepleted plasma Plasma for fractionation (kg)

0Æ06 per 1000 population 40Æ47 per 1000 population 6Æ57 per 1000 population 7Æ46 per 1000 population 2Æ84 per 1000 population 0Æ84 per 1000 population 0Æ018 per 1000 population

The national utilization rate of each product per 1000 population for 2008 ⁄ 2009 is shown below where utilization is defined as units supplied to hospitals or pathology laboratories per 1000 population per annum. The red cell utilization rate varies across individual states and territories from 30 to 42 and has shown differing trends but there has been growth in demand by 3% so far this financial year. This increase in demand is due to increased hospital activity levels including elective surgery as part of a Commonwealth Government initiative to reduce elective surgery waiting lists. There are no national data available on products transfused. Whole Blood Red Cells Platelets Clinical FFP Cryoprecipitate Cryodepleted plasma Intravenous immunoglobulin (g)

0Æ06 per 1000 population 36Æ77 per1000 population 5Æ65 per 1000 population 7Æ16 per 1000 population 2Æ73 per 1000 population 0Æ78 per 1000 population 113Æ19 per 1000 population

The following are the outdate rates at ARCBS for the period 2007/2008 Red Cells Platelets Clinical FFP Cryoprecipitate Cryodepleted plasma

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0Æ3% 5Æ4% 0Æ5% 0Æ3% 0Æ4%

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The following are currently available data relating to outdate rates for hospitals and pathology laboratories to which ARCBS distributed blood components for the period January 2008 to December 2008. Data are supplied from the Electronic Returns Information Capture (ERIC) system which is a voluntary system for reporting blood component discards and the reason for discard. Participation in ERIC has been expanding over the last 2 years and currently represents approximately 65–70% of component issues in Australia. Red Cells (includes whole blood) Platelets Clinical FFP a (Outdated 0Æ7%; Thawed but not transfused 6Æ5%) Cryoprecipitate a (Outdated 2Æ4%; Thawed but not transfused 4Æ6%) Cryodepleted plasma a (Outdated 1Æ2%; Thawed but not transfused 1Æ6%)

4Æ2% 19Æ4% 7Æ2%a 7Æ0%a 2Æ8%a

a

Rate includes those frozen components that were thawed but not transfused. Regulation in Australia currently requires that thawed clinical fresh frozen plasma be transfused within 24 h of thawing, or discarded. If the thawed component has been allocated by a medical practitioner for a designated patient under his or her care, it can however be stored at 2–6C for up to 5 days, after which it must be discarded if not transfused.

Whilst hospital and pathology laboratory outdate rates have been captured in the ERIC system for several years, the number of institutions which have commenced participation over this timeframe mean that the data is not directly comparable from year to year. Question 2 Specialized products are available as listed: Low titre anti-A and anti-B group O apheresis platelets Clinical fresh-frozen plasma (FFP) – 94% from male donors Cytomegalovirus-seronegative platelets and red cells – each 30% total issues Irradiated platelets – approximately 70% (There are geographical differences with respect to the availability of irradiated platelets as a result of logistic issues) Irradiated red cells – 20–25% total issues Components for intrauterine, neonatal and paediatric transfusion Fresh unrefrigerated whole blood Phenotyped red cells Washed red cells Cryopreserved red cells Human platelet antigen (HPA), human leucocyte antigen (HLA) and crossmatch compatible platelets IgA deficient plasma, red cells and platelets Low titre anti-T plasma Secretor plasma Autologous serum eye drops Autologous and directed collections

All red cells and platelets provided by ARCBS are leucodepleted. Additionally, all platelet components are screened for bacterial contamination for the life of the component. Whilst approximately 94% of all clinical plasma components (i.e. fresh frozen plasma, cryoprecipitate and cryodepleted plasma) are derived from male donors, this plasma is not specifically identified and is not provided for any specific patient groups. Specialized components are provided on request and in accordance with the ARCBS Blood Component Information (available at http://www.transfusion.com.au) and a number of clinical practice guidelines, including: • ANZSBT Guidelines for Pretransfusion Laboratory Practice, March 2007 (available at http://www.anzsbt.org.au/ publications/index.cfm); and • ANZSBT ⁄ ARCBS ⁄ NZBS Guidelines for Gamma Irradiation of Blood Components, May 2003 (available at http://www.anzsbt.org.au/publications/index.cfm) Cytomegalovirus (CMV)-seronegative red cells and platelets are provided for CMV-seronegative recipients who are at risk for severe CMV disease, including: • Cytomegalovirus-seronegative recipients of allogeneic or autologous stem cell, bone marrow or solid organ transplants. • Cytomegalovirus -seronegative recipients of highly immunosuppressive chemotherapy e.g. leukaemia, lymphoma. • Recipients of intrauterine red cell transfusions. • Premature ( 7 days – combined ARCBS + hospital > 12 days Platelets – ARCBS 1Æ5–2 days – combined ARCBS + hospital 3–4 days Clinical FFP – ARCBS 5–10 days – combined ARCBS + hospital 10–20 days Question 4 ARCBS does not have access to data regarding the average age of red cells at the time of transfusion. We do, however, monitor the average age at supply of red cells to hospitals and pathology laboratories. ARCBS supply data for the period 1 January 2008 to 31 December 2008 show that the average age at supply of red cells was 6Æ8 days (median of 5Æ1 days). Ninety-one per cent of red cells that were supplied were 14 days or less in age, with 72% being 7 days old or less. It should be noted that the age at issue of red cells is very much dependent upon inventory levels which were very tight during the second half of 2008. There is need for a balance between having sufficient red cells to meet demand but not having too many such that the age profile of the inventory is negatively impacted. ARCBS is monitoring the discussions and debate on the age of red cells at transfusion closely, and is actively engaged with the broader clinical community on this issue. We support the need for further data, including carefully designed, prospective controlled trials, to determine whether there are any patient groups that may benefit particularly from the provision of younger red cells. This

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position appears to be shared by the broader transfusion community within Australia. ARCBS actively supports and participates in hospital based continuous improvement programs which focus on appropriateness of use and patient blood management. Prior to implementing any change, we would consult with stakeholders and perform modelling and feasibility studies on the potential impact of provision of younger red cells and ⁄ or implementing a shorter red cell shelf life. A shorter product expiry would impact upon a number of aspects of blood manufacture and provision, including ARCBS donor management, collection centre activities, testing and processing arrangements, as well as hospital ⁄ laboratory inventory holdings, delivery schedules and other operational activities. Question 5 ARCBS does not have access to data regarding the average age of platelets at the time of transfusion. We do, however, monitor the average age at supply of platelets to hospitals and pathology laboratories. ARCBS supply data for the period 1 January 2008 to 31 December 2008 show that the average age at issue of platelets was 1Æ9 days (median of 2 days). Ninety-six percent of platelets that were supplied were 4 days old or less, with 80% being 3 days old or less. The implementation of bacterial contamination screening of all platelets in April 2008 has necessitated a slight delay in platelet availability as all platelet components must now be held for 24 h after collection prior to sampling. This has resulted in fewer platelets being issued at Day 1. However, the highest proportion of platelets is still being issued at Day 2. As noted above, ARCBS does not have access to data regarding the average age of platelets at the time of transfusion. The following data relates to the average age at supply of platelets to hospitals and pathology laboratories for the period May 2008 to October 2008. Apheresis platelets

Pooled platelets

Day 0 – 0% Day 1 – 22Æ4% Day 2 – 28Æ0% Day 3 – 22Æ2% Day 4 – 20Æ8% Day 5 – 6Æ6%

Day 0 – 0% Day 1 – 12Æ5% Day 2 – 35Æ2% Day 3 – 19Æ9% Day 4 – 23Æ4% Day 5 – 9Æ0%

measures, local clinical studies would be expected prior to any change. There has been no change to platelet shelf life in Australia with the introduction of bacterial screening in April 2008, however, substantial efforts were made to minimize effects on processing and supply to hospitals. Platelets are available for release following sampling, which occurs at 24 h after collection. Fewer platelets are now issued on day 2 and slightly more platelets are now issued on day 3 compared with before implementation of bacterial screening, however there has been no major impact on age of platelets at issue overall. Question 6 Pathogen reduction technologies remain under active investigation. Currently, this is within our Research & Development sector, with no planned operational validations until the 2010 ⁄ 2011 year if progress is approved. Platelet additive solution (PAS) is currently used for all buffy coat derived pooled platelets at a residual plasma concentration of approximately 30%. Work will be performed during 2009 ⁄ 2010 to continue investigations of the use of PAS in apheresis platelets and to determine whether the residual plasma content can be reduced in both apheresis and pooled platelets. Blood substitutes are not currently being actively investigated although the ARCBS will continue to closely monitor developments which may be influential in provision of universal red cells, new red cell additive solutions, prion testing and removal options, new methods of bacterial testing and stem cell alternatives. P. A. S. Hetzel National Operations Manager Australian Red Cross Blood Service Level 6, 464 St Kilda Road Melbourne, VIC, Australia 3004 E-mail: [email protected] J. K. Wong Australian Red Cross Blood Service Level 6, 464 St Kilda Road Melbourne, VIC, Australia 3004 E-mail: [email protected]

M. Horvath & G. C. Leitner

Question 1 Extending the shelf life of platelets above the current 5 days is not under active consideration in Australia at the present time although it would offer the potential to improve platelet availability during holiday periods and during times of platelet shortage. However, the Australian regulator has indicated that, in addition to demonstration of maintenance of acceptable product quality using in vitro

• Red cells are collected by the Red Cross institutions and are distributed around Austria. We receive these packed red cells (PRBCs) from the Viennese centre. While the Red Cross produces also platelet concentrates (PCs) and fresh-frozen plasma (FFPs) for most Viennese hospitals, we produce PCs for the Medical University. We performed about 3800 platelet apheresis procedures thereby

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about 5400 PCs were produced. Five PBRCs and 84 PCs expired before use.

Question 2 •





All patients undergoing bone marrow (BM) or peripheral blood stem cell transplantation (PBSCT), and newborns receive CMV-negative single donor platelets. All blood products are irradiated for these patients (30 Gy), for all patients undergoing chemotherapy or solid organ transplantation, newborns until the age of 6 months, patients with acquired or congenital immunodeficiency syndrome, patients suffering from inflammatory bowel disease and recipients of blood components donated from relatives receive irradiated blood products as well [1,2]. Granulocyte concentrates are provided for immunocompromised patients with a peripheral WBC count < 0Æ5 g ⁄ l and bacterial or fungal infections. A prerequisite for granulocyte transfusion is the insufficiency of antibiotics and ⁄ or antimycotics for at least 3 days and the expected recovery of the patient’s bone marrow. All granulocyte concentrates are irradiated prior to transfusion. Most recipients are children. Plasma-depletion of blood components is performed in case of allergic or anaphylactic reactions to the plasma. All red cell concentrates transfused to recipients smaller than 2 kg body weight are also plasma depleted.

Question 3 • The blood products are delivered according to the ‘firstin-first-out’ principle. In general, our inventory management follows the same rule. Of course components produced on special requests (i.e. granulocytes) are delivered as soon as possible.

Question 4 • Children up to 2 years receive red cell concentrates which are not older than 14 days. For all other transfusions, we have no overall survey. Overall, PRBCs are about 21 days old upon receiving them from the Red Cross and are delivered to the patient within 10 days.

• Extended storage is detrimental to platelet function. [4]. • We considered implementation of pathogen inactivation to circumvent irradiation and CMV negative donor selection [5].

References 1 Council of Europe: Guide to the Preparation, Use and Quality Assurance of Blood Components, 11th edn. Strasbourg Cedex, Council of Europe, 2005. 2 Australian and New Zealand society of blood transfusion inc.: Guidelines for Gamma Irradiation of Blood Components, 1st ASBT edn. Sydney, Australia: Australian and New Zealand society of blood transfusion inc., 1996, revised 2003. Available at http://anzsbt.org.au/publications/documents/ANZSBTguide_ May03pdf. 3 Stiegler G, Leitner G, Jurko S, Gerhartl K, Panzer S, Ho¨cker P: Five-day storage of apheresis platelet concentrates in the new additive solution T-SolTM: changes of metabolic markers. Infus Ther Transfus Med 2002; 29:18–22. 4 Jilma-Stohlawetz P, Horvath M, Eichelberger B, Koren D, Jilma B, Panzer S: Platelet function under high-shear conditions from platelet concentrates. Transfusion 2008; 48:129–135. 5 Isola H, Kientz D., Wiesel ML, Laforet M, Ohlmann P, Waller C, Mendel I, Raidot JP, Kandel G, Cazenave JP: Implementation of photochemical inactivation (INTERCEPT blood system for platelets) in a Regional Blood Center. Presented at the XVII International Society of Blood Transfusion (ISBT) Regional Congress, Madrid, Spain, June 23–27, 2007. M. Horvath Department of Blood Group Serology and Transfusion Medicine Medical University of Vienna Waehringer Guertel 18-20 A – 1090 Vienna Austria G. C. Leitner, MD Department of Blood Group Serology and Transfusion Medicine Medical University of Vienna Waehringer Guertel 18-20 A – 1090 Vienna Austria E-mail: [email protected]

Question 5 • The average age of platelets delivered to the patients is 48–60 h. We produce exclusively apheresis platelets. • Our jurisdiction is considering extension of shelf life from 5 days up to 7 days, which would require bacterial testing of all products. • An extended shelf life alleviates inventory management and reduces the wastage rate of platelets.

Question 6 • We implemented additive solution as storage solution for PCs, which makes platelet substitution blood group independent [3].

H. Schennach & W. Nussbaumer 1. Austria has nine federal states and 8 315 000 (Source: Statistik Austria 2007, www.statistik.at) inhabitants. The population of the states determines also the size of the 10 regional blood centres, all of them working independently. About 95% of blood donations are carried out by the regional Red Cross blood donor services and to a minor degree by other institutions. This ratio is unchanged since 1950, when the Red Cross started its first blood donation service. However, 61% of the annually 450 000–500 000 whole

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blood units are further prepared by and a slightly higher amount of screening tests are performed in Red Cross blood centres. The remaining 39% are prepared in hospitals, of which two sites are university institutes, one site a hospital based institute in close relationship to a medical university and the remaining three sites are hospital based centers. As stated above the blood centers work independently. So inventories are not moved in routine, but based on an organized structure in times of regional shortages. Information about residual capacities of all regional blood donation services is daily updated in an internet database visible for the responsible persons of the blood centers. The shelf life of our blood components is as follows: Red cells: 42 days Platelets: 5 days; 1 centre (Innsbruck, Tyrol) has got the approval to extend to 7 days Plasma: 36 months if stored below )25C The number of produced blood components in Austria given as a total number and units per 1000 population is listed below: (inhabitants 2007: 8 315 000 (Source: Statistik Austria, www.statistik.at) Whole blood total Red Cells in SAG_M_ Platelets (Apheresis) Platelets (Pool) Plasma (quarantine) SD-Plasma (Octaplas) Plasma (fractionation)

478 106 468 332 29 685 25 316 24 442 107 509 147 340

(57Æ49 ⁄ 1000 ⁄ year) (56Æ32 ⁄ 1000 ⁄ year) (3Æ57 ⁄ 1000 ⁄ year) (3Æ04 ⁄ 1000 ⁄ year) (2Æ94 ⁄ 1000 ⁄ year) (12Æ93 ⁄ 1000 ⁄ Year) (17Æ72 ⁄ 1000 ⁄ year)

The utilization rate and the numbers of outdated units of the above blood components are as follows: (number of inhabitants 2007: 8 315 000 Source: Statistik Austria, www.statistik.at)

Utilization rate: Red cells Platelets (Apheresis) Platelets (Pool) Plasma (quarantine) SD-Plasma (Octaplasma) Plasma (fractionation)

427 333 26 675 n.a. 21 880 106 909 139 467

(51Æ39 ⁄ 1000 ⁄ year) (3Æ21 ⁄1000 ⁄ year) (2Æ63 ⁄ 1000 ⁄ year) (12Æ86 ⁄ 1000 ⁄ year) (16Æ77 ⁄ 1000 ⁄ year)

Outdated components: Red cells Platelets (Apheresis) Platelets (Pool) Plasma (quarantine)

2Æ260 out of 48Æ638 790 out of 6Æ464 not used in our center 26 out of 13Æ876

2. In our center, Methylene-blue inactivated plasma for transfusion is now replacing quarantine plasma and SD-plasma, being used for all recipients. Irradiated blood

components are provided for immuno-compromised patients on demand, ‘fresh blood’ or if not available washed red cells for infants below 1 year of age. Washed red cells and washed platelets are transfused to patients with a history of allergic reactions or known IgA-deficiency. Platelets in additive solution (with the goal to reduce allergic side-effects and to avoid washing of platelets in cases of ABO incompatible transfusions) are our standard platelet concentrate. 3. In our blood center, the ‘first-in-first-out’-rule is applied to most of the blood components. Those components with rare blood group phenotypes are stored separately and won’t be subject to this practice. Blood components delivered to the regional hospital blood banks are not older than 14 days according to the fact that they will be stored there for an additional time until transfused to a patient. In most of the Austrian federal states the blood component producer has no insight in the inventories of the hospital blood banks. Regular meetings of the responsible persons of the blood establishment and of the hospital blood banks help to optimize the inventories of both parties. The target inventory level for packed red blood cells is 7 days, for plasma for transfusion 2 months, and for platelets 3 days. 4. The average age of our red blood cell components at the time of transfusion was calculated as follows: Group 0 Group A Group B Group AB

15Æ4 13Æ3 24Æ2 24Æ3

± ± ± ±

9Æ4 days 8Æ7 11Æ2 11Æ9

In Austria, we are observing very carefully the recent publications concerning the age of red blood cells at the time of transfusion and the possible impact on the patients transfused. At the moment there is consensus that these data are not sufficient to change our strategies. This might be the case when more prospective and well randomized studies are available. Then, depending on the proposed shelf life, it could have a major impact on our inventory management. We would have to decrease our stocks to an approximately 4 days-reserve, which could cause problems in emergency situations. This would also have an impact on the structure of the Austrian contingency plan. 5. The average age of our apheresis derived platelet concentrates at the time of transfusion is expressed as mean ± SD and listed below: Group 0 Group A Group B Group AB

3Æ2 3Æ0 3Æ1 3Æ2

± ± ± ±

0Æ9 0Æ9 1Æ0 1Æ0

Pooled platelet concentrates are not produced and transfused in our center.

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Regulated by the Austrian ’Verordnung der Bundesministerin fu¨r Gesundheit und Frauen betreffend Arzneimittel aus menschlichem Blut’ (BGBL. II Nr 187 ⁄ 2005 appendix B) an extension of platelet shelf life to 7 days is permitted under the condition that a method to reduce the bacterial contamination is included (culturing or pathogen inactivation). Our center has got the permission to store platelets up to 7 days. The rationale behind (at least in our centers strategy) is to reduce the number of outdated platelet units and to simplify the logistics of platelet supply especially on weekend and during holiday seasons. That strategy leads to a reduction of outdated units and to a better utilization of the existing donor pool (reducing the number of donations per donor per year, better preselection of platelet donors based on platelet precount). In addition, a second bacterial culture was implemented on day 4, and an adjustment of accompanying quality measures was also introduced. 6. The use of blood substitutes is not discussed in our institution and the whole country for the moment. Pathogen inactivation for plasma has been used since 6 months in our center (Methylene-Blue) to provide single donor plasma and to help to manage a plasma support from male donors to minimize the risk of TRALI. Platelet additive solutions are also used in our center for all of our platelets to reduce the amount of transfused plasma for the recipient, to increase the donor’s comfort by reducing the extracorporeal volume per donation and to allow an ABO-mismatched platelet transfusion if the matched group is not available. Production of double dose platelet concentrates and double dose red cell units makes it easier for us to supply hospitals with units of rare blood groups and ⁄ or to support patients with multiple blood group antibodies. H. Schennach, MD & W. Nussbaumer, MD Central Institute for Blood Transfusion & Department of Immunology Anichstrasse 35 A-6020 Innsbruck Austria E-mails: [email protected] [email protected]

K. Genoe

Question 1 The Red Cross organizes the major part of blood transfusion (collection and distribution) in Belgium and there are a couple of smaller blood institutes in Belgium. The blood institute of Red Cross-Flanders and the blood institute of its Walloon counterpart organize 95% of the blood system. Red Cross-Flanders collects blood and blood products in Flanders and distributes blood and blood products to the

hospitals in Flanders. There is no movement of inventory from one region to another. The shelf life of the different products is for : • Red Cells: 42 days • Platelets: 5 days • Fresh Frozen Plasma (FFP): 1 year (conservation at < )30C) • Fresh Frozen Plasma: 6 months (conservation between )30C and )25C) Red Cross-Flanders collects annually the following units per 1000 inhabitants • Blood: 55.63 • Plasma: 8.76 • Single donor platelets: 2.15 In 2008, Red Cross-Flanders delivered the following products at the hospitals per 1000 inhabitants • Red Cells: 52.35 • Single dose platelets: 1.27 • Platelet pools (in EEE): 33.74 • Fresh Frozen Plasma: 9.63 For the year 2008 the outdate rates of the prepared products are the following : • Red cells: 0.51% (0.67% in 2007) • Single dose platelets: 3.98% (4.26% in 2007) • Platelet pools (in EEE): 7.15% (8.01% in 2007) • Fresh frozen plasma: 0.36% (0.21% in 2007)

Question 2 All red cell concentrates and platelet concentrates are standardized leucodepleted blood products. FFP is standardized virus-inactivated with the methylene blue method. Other specific products: • Fresh blood products: s Exchange or massive transfusion for neonates s Intra-uterine transfusion • Cytomagalovirus (CMV) negative blood products; s Intra-uterine transfusion s Unrelated stem cell ⁄ bone marrow transplantation when donor and acceptor are CMV negative • Irradiated blood products s Patients at risk for TA-GVHD s Intra-uterine transfusion s Premature neonates with a body weight > 1500 g s Autologous and allogeneic stem cell transplant patients s Acquired or congenital immunodeficiency • Phenotyped red cells (Fy, Jk, Kell,…) s Patients with red cell antibodies • Phenotyped platelets (HLA, HPA) s Thrombocytopenia in patients with HLA ⁄ HPA antibodies • Washed red cells: s Patients with IgA deficiency and IgA antibodies

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Patients with severe allergic reactions against plasma proteins Frozen red cells, defrozen and irradiated s Anaemic patients with a special phenotype when compatible standardized red cells are not available Reconstituted whole blood: s Exchange transfusion for neonates with mostly haemolytic disease of the new born Red cell concentrate for intrauterine transfusion (O), fresh, SAGM removed, haematocrit between 0.7 and 0.8, irradiated) s Foetus with severe prenatal anaemia Volume reduced single donor platelet concentrate: s Neonates with severe thrombocytopenia or thrombocytopathy Virus-inactivated cryosupernatant plasma: s TTP resistant to therapy with FFP s











Question 3 Red Cross-Flanders uses as an inventory management practice ‘first-expired-first-out’. However, when a patient needs a specific blood product the FEFO-practice is not being followed. The blood institute organizes it’s inventory level separately and not in an integrated fashion with the hospital user. However, this is one of the projects that will be implemented while installing a new bloodbank software. Our inventory level is being placed on a level of 5 days inventory and for O+, O) and A) it’s a 7 days inventory.

Question 4 The average age of the red-blood-cells by blood group at the moment of the delivery to the hospitals is the following. (It is not possible at this moment to provide the average age at the time of transfusion): • Red Cells O+: 5 days • Red Cells A+: 6 days • Red Cells B+: 12 days • Red Cells AB+: 8 days • Red Cells O): 5 days • Red Cells A): 6 days • Red Cells B): 7 days • Red Cells AB): 9 days Red Cross-Flanders has data on the average age of redblood-cells at the moment of delivery to the hospital user, but there are currently in the blood institute no data on the average age of red-blood-cells at the time of transfusion. A change in jurisdiction will not affect the average age at delivery. Type & screen has certainly to be considered as a method which ameliorates the inventory management by affecting the average age of transfusion.

Question 5 The average age of platelets at the moment of the delivery to the hospitals is the following. (It is not possible at this moment to provide the average age at the time of transfusion) : • Whole blood derived platelets: 3 days • Single donor platelets: 3 days There is no consideration being given in the jurisdiction to extend the shelf life of platelets.

Question 6 For the inventory management of platelets: third generation PAS (SSP+, Composol…) in combination with pathogen inactivation to extend storage to 7 days K. Genoe Chief operations officer Red Cross – Flanders Motstraat 40 B-2800 Mechelen, Belgium E-mail: [email protected] Tel. +32 16 31 61 01

J. M. Cioffi & F. N. Givisiez

Question 1 Brazil is a federation made up of 26 states and a Federal District. Its 5565 counties, spread over 3 287 597 square miles (47% of South America), house 189 612 814 inhabitants. To manage the country’s blood bank system, a system of ‘National Blood, Component and Hemoderivate Guidelines’ was established, with the goal of assuring the nation’s self-sufficiency and maintaining consistency in all levels of government relating to this area. These guidelines are under the jurisdiction of the National Health System, and were developed cooperatively by the nation-wide network of Hemoderivate Centres, public and private. All these institutions and policies are governed by the Ministry of Health. Therefore, the National Blood System follows a de-centralized structure created around national guidelines. The Hemominas Foundation operates in the Brazilian state of Minas Gerais, a region with 853 counties over 226 460 square miles and a population of approximately 19 million. The foundation is a public blood transfusion centre, and is part of the National Blood System. It operates as a centralized blood system, with regional centres, coordinated by a central management unit, from which all technical and management directives spread to the state network. There are 19 regional units in the network, responsible for collection, processing and distribution of blood and components, supplying over 450 hospitals and clinics statewide.

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To properly manage the entire system, Central Management’s Technical and Scientific Directory is informed daily of blood supply in each one of the 19 regional units, and redistributes it as dictated by local necessity. Each unit maintains a basic supply, to guarantee normal distribution during 72 h, and has to monitor regional demand accordingly. Hemominas complies with Federal law in establishing expiration dates for blood components, as follows:

Product

Expiration

Platelets Red-blood-cells (CPDA1) Red-blood-cells (SAG-M Fresh Frozen Plasma Cryoprecipitate

5 days 35 days 42 days 1 year 1 year

The tables below show collection and utilization rates: Production Chart per 1000 inhabitants

Unit collected per 1000 inhabitants per year Product collected

2004

2005

2006

2007

2008

Whole blood Apheresis platelets Total

16Æ28 0Æ10 16Æ39

16Æ48 0Æ11 16Æ59

16Æ73 0Æ12 16Æ85

17Æ26 0Æ08 17Æ34

16Æ12 0Æ11 16Æ23

Utilization rate per 1000 inhabitants per year Product transfused

2004

2005

2006

2007

2008

Red-blood-cells Platelets concentrates Fresh frozen plasma

14Æ74 5Æ23 3Æ12

15Æ04 5Æ51 3Æ30

15Æ15 5Æ60 1Æ52

15Æ44 6Æ25 3Æ27

15Æ70 7Æ14 3Æ54

To calculate utilization rate, we considered units transfused per 1000 inhabitants. The table below shows data regarding outdate rate for each component:

Outdate rate (%) per year Product

2004

2005

2006

2007

2008

Red-blood-cells Platelet concentrates Fresh frozen plasma Cryoprecipitate

6Æ17 24Æ36 1Æ03 9Æ32

4Æ90 25Æ53 4Æ88 10Æ54

4Æ07 23Æ82 0Æ66 3Æ68

3Æ92 23Æ16 0Æ83 4Æ14

3Æ28 21Æ98 0Æ20 3Æ64

Question 2 Hemominas does not perform serological tests for cytomegalovirus (CMV) or pathogen inactivation. However, in compliance to federal law, it leucoreduces cellular components (red-blood-cells and platelet concentrates) for underweight newborns, CMV-negative pregnant women, transplant patients and chemo ⁄ radiotherapy recipients. Hemominas also irradiates components for immunosupressed transplant patients and intrauterine transfusions. The feasibility of pathogen inactivation in some components (fresh frozen plasma, for example) is currently under evaluation.

Question 3 Each of the 22 Hemominas regional units has determined its target inventory levels of red-blood-cells to guarantee normal distribution during 72 h, inside the area it services. This target inventory is calculated according to previous distribution needs of red-blood-cells to hospitals and clinics. All units subscribe to ‘first-in-first-out’ operation, with the exception of priority use of < 7-day-old red-blood-cells for specific cases, such as underweight newborns, intrauterine transfusions and exsanguine transfusions. As Hemominas attends many establishments throughout the state, hospitals are directed to a nearby unit, helping them maintain their own supply.

Question 4 Hemominas Foundation prioritizes the attending to neonatal patients and intra-uterine transfusion. At the present moment it is not possible to define priority in other patients groups for the use of younger red-bloodcells. If proven that the use of younger red-blood-cells is better for all patients, we will have great difficulty in offering this product and will have to plan new practices for supply control. In our current reality, the exclusive offer of younger red-blood-cells is impossible. During the last year, the average age of red-blood-cells at the time of transfusion was 12 days.

Question 5 In Brazil, platelets expiration date is of 5 days, and its use for a longer period is forbidden. During 2008, the average age of randomic platelet concentrates at transfusion was 3 days and of apheresis platelet concentrates was 2 days.

Question 6 At Hemominas Foundation virus inactivation of fresh frozen plasma is a goal; however, to date we don’t have this product to offer to the population.

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Another technology which we will start soon is freezing red-blood-cells of rare phenotypes. J. M. Cioffi Technical Director HEMOMINAS Foundation Rua Gra˜o Para´, 882 Belo Horizonte - MG - 30150-340 Brazil E-mail: [email protected] F. N. Givisiez Quality Control Manager E-mail: [email protected]

Product

Annual collections ⁄ 1000 population

RBC 35Æ8 Platelets, Pooled 3Æ8 (buffy coat derived) Platelets, transfusion 0Æ5 dose (PRP derived)a Platelets, Apheresis 1Æ6 FP ⁄ FFP 6Æ3 Cryoprecipitate 1Æ8 Cryosupernatant plasma 1Æ8

Annual issues ⁄ Centre Hospital 1000 outdate outdate population rate (%) rate (%) 32Æ6 2Æ3

0Æ5 4Æ4

1Æ7 19Æ0

0Æ4

12Æ6

22Æ8

1Æ5 5Æ6 1Æ0 0Æ7

2Æ2 0Æ0 0Æ0 0Æ5

2Æ4 1Æ2 1Æ7 2Æ4

a

Calculation assumes transfusion dose of 5 PRP units.

Question 2 D. V. Devine, M. Rogerson & D. Howe

Question 1 The blood system in Canada operates as a centralized system with two managing organizations: Hema-Quebec operates the blood system in Quebec and Canadian Blood Services operates the blood system in the other provinces and territories of Canada. The answers to the inventory questions contained in this contribution speak to the operations of Canadian Blood Services. Please see the submission from Hema-Quebec for a description of the situation in Quebec. Canadian Blood Services operates with a national inventory management approach that sees us moving blood products from one region of the country to another as required. Platelet products in Canada have an allowable shelf life of 5 days, even though all of the platelet inventory in the country is subjected to culture-based bacterial testing by the blood product producer. Red-blood-cells may be stored for a maximum of 42 days. All red-blood-cells and platelet concentrates are subjected to prestorage leucoreduction by filtration. Plasma for transfusion, cryoprecipitate and cryosupernatant plasma all have a maximum frozen storage time of 1 year. Thawed plasma must be used within 24 h. The utilization rates for products produced by Canadian Blood Services and their estimated outdate rates are given in the Table below. Because, we do not capture consistent information concerning the transfusion of these products, we have defined utilization in this setting as the issue of the product from the blood centre to hospitals. In addition, these data reflect a mix of platelet products derived from whole blood as during 2008 most Canadian Blood Services production sites converted to buffy coat platelet production from the platelet-rich plasma method.

At the present time, Canadian Blood Services provides CMV-negative blood products and irradiated blood products (red cells and platelets) for certain patient groups such as neonates and immunosuppressed patients. Phenotyped red cells and platelets of specific HLA-type or platelet antigen group (HLA) are also provided for patients who require them because of alloimmunization. ‘Fresh’ red cell concentrates are also made available to paediatric institutions. For patient with chronic dependency on red cell transfusions such as thalassemia patients, patients with IgA deficiency, immunocompromised patients or patients with a history of reactions to blood products, we provide washed red cells. We are considering the introduction of platelets suspended in platelet additive solution as well as pathogen inactivation technology for plasma and cellular products. We are also actively seeking to implement a paediatric dose of platelets in a validated container that can support multiple days of storage.

Question 3 The majority of product is handled on a first in first out basis; however this is not the case for all products. Some distant, rural hospitals may be issued fresher product to minimize the amount of restocking that may be needed. There are also certain indications whereby blood components that have been most recently released into inventory are requested by some institutions, for example, red cells for use in neonates. Canadian Blood Services maintains a national inventory of blood components across its various sites. Product is redistributed as needed to ensure a constant supply of product regardless of the geographic location. Hospital inventories are part of this national inventory; however, Canadian Blood Services does not have real time access to this information. Sentinel hospitals are requested to provide inventory snapshots on a daily basis. In addition, Canadian Blood Services

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shares information on its local and national inventory levels of products with hospitals on a daily basis. In several areas of the country, local hospitals have a redistribution program which moves older units from hospitals that have not used them to hospitals with high throughput. These are managed on a local basis and not by Canadian Blood Services. Canadian Blood Services sets inventory targets for red cell concentrates based on a site’s predicted daily demand. From that Days on Hand (DOH) targets are set with an optimal inventory being defined as 5–8 DOH. These levels are currently under review to ascertain their adequacy for business continuity.

The age of cellular products at transfusion is receiving increasing attention in North America. A study in critical care patients of red-blood-cell transfusions has recently commenced in Canada; it uses 8 days as the storage demarcation between old and young cells. Management of inventory using such a short shelf for all patients would be very problematic for our blood system. Should the results of ongoing randomized controlled trials support a reduced storage time of red cells for some patient groups, at the very least we would seek to provide younger red-blood-cells for those patients. As noted above, fresher red-blood-cells are routinely used for paediatric patients, with the decision as to allocation being made by the hospital blood bank.

Level

DOH

Question 5

Emergency Serious Minimum Optimal Maximum Excess

0–1Æ5 1Æ5–3 3–5 5–8 8–10 > 10

Although we are lacking complete data for our hospital customer base, we believe that the average platelet concentrate is at day 4 of storage at the time of transfusion with a large proportion also transfused at day 5. Although the outdate rate for platelets at hospitals is nearly 20%, the data for age at issue from the blood centre are reported below.

Frozen products have a far more variable demand pattern and as such our inventory targets are set considerably higher. For FP ⁄ FFP Canadian Blood Services targets a 2 week inventory whereas for cryoprecipitate a 4 week inventory is targeted. Platelet inventories require a different strategy. Production quotas follow more of a ‘Just in Time (JIT)’ approach with minimal inventory being held (2–3 days). Daily production plans are based on projected hospital demand which can vary significantly depending on the presence of certain activities such as oncology clinics.

Question 4 In Canada, there is no centralized data base that records the age of blood at the time of transfusion. A recent study of representative medical centres across Canada indicated that the median age of red cells at transfusion is 15 days (Alan Tinmouth, University of Ottawa, personal communication). From the blood system operator perspective, we track the age of products at the time of issue, with the results seen in the following Table.

National average Range across individual blood centres

% RBC issued 7 days or less after collection

% RBC issued 14 days or less after collection

% RBC issued 21 days or less after collection

66 49–74

91 87–96

96 93–98

National average Range across individual blood centres

% Platelets issued 2 days or less after collection

% Platelets issued 3 days or less after collection

% Platelets issued 4 days or less after collection

34 23–47

58 47–68

80 73–85

Because of a relatively high percentage of outdated platelet products with a 5 day storage limit, we are interested in the possibility of extending storage to 7 days. We are presently gathering data to understand what the residual risk of bacterial contamination is in buffy coat platelet pools that were tested just after manufacture by bacterial culture. The results of this study will provide us with data to allow a decision to be made concerning whether we will pursue the possibility of 7 day storage. We anticipate that any extension to 7 days will be paired with a second level of bacterial test to ensure product sterility at the time of transfusion. The quality of platelets at day 7 of storage will also enter into the decision-making around the extension of platelet storage.

Question 6 Our organization is actively considering the use of platelet additive solutions as a means to help with the management of platelet inventory with respect to ABO incompatible transfusions, and further reduction in TRALI risk; we

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already have a predominantly male plasma strategy in place. We are presently piloting the use of genotyping to create a database of donors with extended phenotypes. It is our expectation that our overall ability to meet hospital demand for rare or complicated phenotypes for alloimmunized patients will improve as a result. D. V. Devine M. Rogerson D. Howe Canadian Blood Services 1800 Alta Vista Drive Ottawa, ON K1G 4J5, Canada E-mail: [email protected]

RBC 29Æ9 WBDPC 13Æ1 (not pooled) Apheresis 0Æ9 platelets Apheresis 1Æ1 plasma WBD plasma 6Æ2 Cryoprecipitate 1Æ7 Cryosupernatant 1Æ5

29Æ2 9Æ5

29Æ2 7Æ3

29Æ2 6Æ1

29Æ6 4Æ1

29Æ9 4Æ3

1Æ6

2Æ1

2Æ6

3Æ1

3Æ2

1Æ0

1Æ0

1Æ0

1Æ0

0Æ9

6Æ2 1Æ5 1Æ2

6Æ0 1Æ8 1Æ2

6Æ2 2Æ1 1Æ1

6Æ6 2Æ1 1Æ0

6Æ9 2Æ2 1Æ2

a

Fiscal year: from April 1 to March 31 WBDPC, whole-blood derived platelet concentrates. WBD plasma, whole-blood derived plasma.

G. Delage, C. Sarappa & Y. Charbonneau 1. In Canada, two operators (He´ma-Que´bec and Canadian Blood Services) manage the country’s blood system. He´ma-Que´bec covers the province of Quebec, which represents about a quarter of the Canadian population (7 750 500 ⁄ 33 441 300 for 2008). Canadian Blood Services covers the other nine provinces and the territories. In Que´bec, the blood system is managed by one operator working out of two establishments. Inventory is moved from one establishment to another, mostly platelets and plasma. Movement of red-blood-cells (RBC) concentrates is more limited. The shelf life of the products can be found in the following table: RBC Whole-blood derived platelet concentrates Apheresis platelets Plasma, cryoprecipitates, and cryosupernatants

42 days 5 days 5 days 1 year

The number of units collected annually per 1000 population is found in the next table:

Whole blood Apheresis platelets Apheresis plasma

2003– 2004– 2005– 2006– 2007– 2008– 2004a 2005 2006 2007 2008 2009

2003– 2004a

2004– 2005

2005– 2006

2006– 2007

2007– 2008

2008– 2009

34Æ3 1Æ0

32Æ2 1Æ6

32Æ8 2Æ2

30Æ7 2Æ7

31Æ6 3Æ2

31Æ7 3Æ4

1Æ3

1Æ1

1Æ0

1Æ1

1Æ1

1Æ2

a

Fiscal year: from April 1 to March 31

The utilization rates (defined here as products shipped to hospitals) for the various products per 1000 population per year are found in the following table:

Outdate rates at He´ma-Que´bec are as follows:

RBC (%) WBDPC (%) Apheresis platelets (%) Total platelets (%) Cryoprecipitate (%) Plasma (%)

2003– 2004a

2004– 2005

2005– 2006

2006– 2007

2007– 2008

2008– 2009

2Æ7 23Æ5 1Æ17

2Æ29 31Æ23 0Æ41

2Æ19 23Æ59 0Æ56

0Æ37 35Æ50 0Æ30

0Æ69 38Æ75 1Æ57

0Æ62 20Æ06 2Æ48

17Æ77

17Æ28

9Æ91

11Æ50

9Æ42

6Æ18

3Æ25

3Æ42

1Æ68

0Æ01

0Æ01

0Æ14

0Æ83

0Æ05

0Æ18

0Æ00

0Æ00

0Æ05

a

Fiscal year: from April 1 to March 31 RBC, red-blood-cells. WBDPC, whole-blood derived platelet concentrates.

In hospitals, outdate rates of RBCs have dropped from 2.3% in 2004–2005 to 1.4% in 2007–2008, the last year for which the Ministry of Health provided data. We have no data on outdate rates for other blood products. 2. We provide the following specialized products: (a) ‘Fresh’ RBC concentrates: We send RBCs < 7 days of age for the transfusion support of certain neonates (particularly those undergoing massive transfusions) and paediatric cardiac surgery patients. We distribute close to 200 such products per week to our paediatric hospitals. (b) Paediatric packs: We send annually 20 000 RBC concentrates to which are attached four empty small satellite bags allowing for collection of aliquots from the main bag which are then detached and sent for transfusion of neonates requiring ‘top-up’ transfusions. This is used by paediatric hospitals to reduce donor exposure of neonates.

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(c) CMV-negative products: Although in Canada all blood products undergo prestorage leucodepletion, we continue to supply CMV-negative products to our customers in accordance with the recommendations of the Canadian Consensus Conference on this issue [1]. In Canada, CMV-negative products are used mainly for the transfusion of CMV-negative pregnant women and CMV-seronegative allogeneic haematopoietic stem cell transplant recipients, as well as for intra-uterine transfusions. (d) Irradiated products: We supply irradiated products for at-risk population groups such as foetuses undergoing intra-uterine transfusions, selected immunocompromised recipients, recipients of cellular blood components known to be from a related donor, recipients of haematopoietic stem cell transplants, and recipients of HLA-compatible platelets. We supply irradiated products on demand and do not request information on medical indication. We issued 14 242 irradiated RBC concentrates and 11 129 irradiated apheresis platelets last year. (e) We are contemplating the eventual introduction of pathogen reduced products. However, we are only in the exploratory phase of this project. 3. In general, our inventory management practice is ‘first-infirst-out’. The only exceptions are for RBC concentrates in that we supply ‘fresh’ products to our paediatric customers (see answer to question 1 above) and to small isolated community hospitals who are at a great distance from our two establishments. These hospitals have in turn made arrangements with hospitals using high volumes of RBC concentrates to rotate stocks and minimize outdating. Inventories are managed separately by He´ma-Que´bec and hospitals. However, there is an integrated plan in place for management of blood component shortages. For RBC concentrates, our minimum target inventory is 4260 (6 days). However, we have been maintaining over 8 days of inventory for the past year. For other blood components, the targets are: WBDPC, 160; apheresis platelets, 127; apheresis plasma, 715; WBC plasma, 1500; cryoprecipitates, 500; cryosupernatants, 1700. 4. The average age of RBCs at distribution to hospitals is 12 days. We have no data on the average age at transfusion. The issue of age of RBC concentrates is of great concern to us. However, up till now, we have not observed an increase in the ordering of ‘fresh’ RBC concentrates by our customers, even though we are monitoring this closely. We are attempting to model the potential impact on our inventory of an eventual reduction in the shelf life of RBC concentrates. We believe that a decrease in shelf life of RBC concentrates will force us either to decrease our targeted levels of inventory or accept an increase in RBC outdating. We hope

that our modelling will allow us to quantify these impacts more precisely. 5. For WBDPC, the average age at distribution is 3.1 days and for apheresis platelets 2.7 days. We have no data on age of platelets at transfusion. At the present time, the shelf life of our platelet products is 5 days. We have no immediate plans for increasing the shelf life of platelets. We will consider the issue if and when pathogen reduction technologies are in place. 6. We are in the process of introducing the production of WBDPC using the Buffy Coat method. However, we do not believe that this will have an important impact on our inventory management of platelet products since 80% of platelet needs are met with apheresis platelets. G. Delage Vice-President, Medical Affairs – Microbiology Hema-Quebec 4045 Cote-Vertu Blvd. St-Laurent, H4R 2W7 Quebec Canada E-mail: [email protected] C. Sarappa Business Analyst Hema-Quebec Canada Y. Charbonneau Vice-president Operations

References 1 Laupacis A, Brown J, Costello B, Delage G, Freedman J, Hume H, King S, Kleinman S, Magulli T, Wells G: Prevention of post transfusion CMV in the era of universal wbc reduction: a consensus statement. Transfusion 2001; 41:560–569

Y. Fu

Question 1 In China, the blood system is managed by a decentralized model. Our inventory is not moved from one geographic region to another. CPDA-1 is used to store whole blood; the shelf life for whole blood is 35 days. MPA is used to store re-suspended red-blood-cell; the shelf life is 35 days, too. The shelf lives for the Fresh Frozen Plasma, Cryoprecipitate, Apheresis Platelet and Whole Blood Derived Platelet are 1 year, 1 year, 5 days and 5 days, respectively. In Guangzhou, the collection rate of each blood type is as follows in 2008: O: 10Æ10 units* ⁄ 1000 population; A: 6Æ86 units ⁄ 1000 population; B: 6Æ25 units ⁄ 1000 population;

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AB: 1Æ77 units ⁄ 1000 population (*1 units equals to 200 ml whole blood or products prepared from 200 ml whole blood) In the Guangzhou blood center, all donations are screened for HBsAg, anti-HCV, anti-HIV, treponema pallidum antibody and alanine aminotransferase (ALT). The qualified rate of samples is 96.48% in 2008. We provide the qualified products to hospitals for clinical use. About the outdate rate, in 2008, the outdate rate of whole blood and RBC concentrates in our Blood Center was 0.0005%. The following data show the outdate rates in the Guangzhou Blood Center. There is a decreasing trend from 2005 to 2008: 2008: 0Æ0005% 2007: 0Æ0025% 2006: 0Æ0027% 2005: 0Æ0144%

Question 2 Our blood center provides irradiated products, Rh negative blood and one-fourth unit whole blood for some specific patient populations. Irradiated products are mainly for immuno-suppressed patients and directed blood for blood relative patients, etc. Rh negative blood is only for Rh negative patients; one-fourth unit of whole blood is for infants and children according to special order. Now we are considering the introduction of leucocyte-reduced products for clinical use.

through adjusting the blood collection by recruiting more donors when there is a shortage of blood and limiting the collection when there is enough inventory.

Question 5 The average age of platelets is 2.5 days at the time of transfusion for apheresis platelets and 2 days for whole blood-derived platelets. No consideration is given in our jurisdiction to extending the shelf life of platelets in our blood center. To improve the transfusion security, we have shortened the shelf life of whole blood-derived platelets from 5 to 3 days.

Question 6 We have not utilized technologies such as blood substitutes, pathogen inactivation, or platelet additive solutions to impact on our inventory management. Y. Fu Guangzhou Blood Center 31 Lu Yuan Road, Guangzhou Guangdong 510095 China [email protected]

D. Šarlija, T. Vuk, M. Strauss Patko, M. Balija & I. Jukic´

Question 3

Question 1

Inventory management practices in our organization are first-in-first-out. We try to keep the inventory levels stable by managing blood collection and the hospital users. Our target inventory levels per day are as follows: • Rh()) frozen blood: s O: 50–300 units s A: 30–200 units s B: 3–200 units s AB: 15–100 units • Suspended red-blood-cell: s O: 1500–7000 units s A: 800–3500 units s B: 800–3500 units s AB: 400–2000 units

The Ministry of Health and Social Welfare (MoHSW) has the legal responsibility for the National Blood Transfusion Service (BTS) policy and structure, the supply of safe blood products and recruitment of blood donors led by Croatian Red Cross and Croatian Institute of Transfusion Medicine (CITM). MoHSW is the Competent Authority in charge of licensing, inspection and haemovigilance. The system is decentralized. There are 34 transfusion centres in Croatia. • Croatian Institute of Transfusion Medicine is the only independent blood establishment, Referential Centre for Transfusion Medicine to MoHSW, performing also pretransfusion testing for some hospitals • Thirty-three transfusion units are organized as hospital departments • 3 ⁄ 33 hospital blood banks are planned to become Regional centres • 17 ⁄ 33 hospital blood banks perform collection of blood from donors, testing of donor’s blood, preparation and storage of blood components and pretransfusion testing of donor’s and patient’s blood • 16 ⁄ 33 hospital blood banks perform only hospital service: store blood components and perform pretransfusion testing.

Question 4 The average age of red-blood-cells for transfusion is < 10 days for O blood type and more than 10 days for the other blood types. There is concern in our jurisdiction about the increasing attention being paid to the age of red-bloodcells at transfusion and the possible impact on recipients. In the Guangzhou blood center, there are no data yet that show younger red-blood-cells are better for patients than older ones. We try to maintain a desirable inventory

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Reorganization of BTS in Croatia was introduced through legislation in year 2006–2008 (transposition of EU Blood Directives) and is in process with the computerization and concentration of activities- nine centres for collection and preparation of blood components, five centres for serological testing and two centres for PCR testing are planned in phase 1. There is one plasma fractionation plant producing only albumin and immunoglobulins. Blood components are often exchanged upon needs from one region to another, especially during summer (tourist season). Allowable storage times are: • Red cells CPD-A1 – 35 days • Red cells in additive solution – 35 days • Red cells, buffy coat removed in additive solution – 35 days • Red cells, washed – 24 h after preparation • Red cells leucocyte-depleted – 35 days • Red cells washed and leucocyte-depleted – 24 h • Platelets recovered prepared from platelet-rich plasma (PRP) or buffy coat – 5 days • Platelets apheresis – 5 days • Platelets washed- 6 h • Plasma, fresh frozen – 1 year • Cryoprecipitate – 1 year • Plasma for fractionation – 1 year Whole blood collection rate is 36Æ1 Apheresis collection rate (platelets and plasma) is 0Æ4 s Utilization rate data is not available, only data of issued blood components available (Table 1) s Outdate rates are only available for CITM (collecting 48% of whole blood in Croatia in 2008 – Table 2) Table 1 Data for Croatian blood transfusion service 2002–2007

WB collected l ⁄ 1000 WB issued l ⁄ 1000 RC issued l ⁄ 1000 PLT random (single dose) issued l ⁄ 1000 PLT apher issued (therapÆ doses) l ⁄ 1000 FFP issued l ⁄ 1000

2002

2003

2004

2005

2006

2007

154Æ236 34Æ7 5Æ973 1Æ35 146Æ936 33Æ11 61Æ556

160Æ800 36Æ2 4Æ592 1Æ03 154Æ685 34Æ86 60Æ739

156Æ705 35Æ3 3Æ785 0Æ85 151Æ024 34Æ03 56Æ689

156Æ663 35Æ3 2Æ527 0Æ57 152Æ038 34Æ26 56Æ838

155Æ359 35 2Æ645 0Æ6 151Æ457 34Æ13 55Æ864

160Æ026 36Æ1 2Æ740 0Æ61 155Æ501 35Æ04 52Æ522

13Æ87 1Æ188

13Æ69 1Æ400

12Æ77 1Æ491

12Æ80 1Æ747

12Æ6 1Æ824

11Æ84 1Æ756

0Æ27 98Æ447 22Æ18

0Æ32 0Æ34 101Æ037 96Æ669 22Æ77 21Æ78

0Æ39 92Æ090 20Æ75

0Æ41 86Æ467 19Æ48

0Æ39 79Æ310 17Æ87

Table 2 Data on collected and outdated RC and PLT for Croatian institute of transfusion medicine (CITM) 2004 Collected 70.316 WB + 1.581 apheresis platelets Outdated 1Æ06 RC % Outdated 7Æ4 PLT %

2005

2006

2007

2008

69.592 WB + 1.796 apheresis platelets 0Æ19

68.552 WB + 1.905 apheresis platelets 1Æ06

68.897 WB + 1.810 apheresis platelets 1Æ02

79.003 WB + 1.785 apheresis platelets 0Æ13

4Æ3

3Æ7

3Æ9

2Æ7

Question 2 Regarding some specialized products CITM provides testing for cytomegalovirus (CMV) negative products only on special demand (incidence of anti-CMV among our donors is about 85%). Blood components are irradiated on demand for immunosuppressed patients (e.g. for bone marrow transplantation, neonates etc.). Irradiation is performed at the hospital and CITM is in the process of purchasing blood irradiator. There is a plan for the introduction of pathogen inactivation of plasma (process validation in progress).

Question 3 The inventory management practice is usually first-in first-out. In case there is a transfusion service with stock in hospital, CITM delivers BC with different expiration date (to be suitable for different kind of patients, e.g. newborns). The same policy is used if CITM delivers BCs directly to hospital department for particular patients. Usual practice is also to deliver RC 14 days (so-called proper storage age) [1]. Other authors commented that there were flaws in designs of these studies, caveats in data analyses and spurious conclusions [2]. Pending the availability of high confidence evidence, if sufficient data accumulated showing the superiority of transfusing younger red cells, HKRCBTS would make the necessary changes in operation to try to shorten storage age of red cells supplied for clinical indications supported by evidence in the literature and international consensus.

Question 5 In Hong Kong, approximately 99Æ5% of the platelet concentrates supplied for clinical transfusion are derived from whole blood donations. Given that platelet concentrates are issued after completing the routine bacterial surveillance testing according to the prevailing screening protocol at the HKRCBTS [3], they are at least 3Æ5 days postcollection. The average age of platelet concentrates at the time of transfusion is therefore 4 days. Previous study at the HKRCBTS showed that, despite routine short-term bacterial culture, a significant risk of bacterial contamination remains at both 5 and 7 days after collection [4]. For now, the HKRCBTS determines that shelf life of platelet concentrates should remain at 5 days. As such, quality factors of extending platelet shelf life to 7 days have not been put into the agenda at the moment.

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Question 6 The HKRCBTS has been supplying leucodepleted red cells to patients who are dependent on regular transfusion. We are planning to gradually increase the supply and also to extend the programme to cover platelet concentrates. Because of the limited supply, we need to work out the target patient groups to receive the leucodepleted products and the necessary inventory levels. To further enhance blood safety, the HKRCBTS is planning to supply pathogen inactivated FFP, initially to paediatric patients only. The programme may be expanded in future to cover other blood components and target patient group. We therefore also need to work out the necessary inventory management.

References 1 Zimrin AB, Hess JR: Current issues relating to the transfusion of stored red blood cells. Vox Sang 2009; 96:93–103 2 Dzik W: Fresh blood for everyone? Balancing availability and quality of stored RBCs. Transfus Med 2008; 18:260–265 3 Liu HW, Yuen KY, Cheng TS, Lee KB, Chua EK, Ho PL, Lin CK: Reduction of platelet transfusion-associated sepsis by short-term bacterial culture. Vox Sang 1999; 77:1–5 4 Lee CK, Ho PL, Lee KY, Tsui GT, Chua E, Tsoi WC, Lin CK: Estimation of bacterial risk in extending the shelf life of PLT concentrates from 5 to 7 days. Transfusion 2003; 43:1047–1052 C. K. Lin, W. C. Tsoi and C. K. Lee Hong Kong Red Cross Blood Transfusion Service Hong Kong China E-mail: [email protected]

K. Barotine-Toth

Question 1 • In Hungary, the blood system is a centralized system. These blood centres were reorganized in 1998 and the Hungarian National Blood Transfusion Service (HNBTS) was established based on the principle of centralization and independence from the hospitals that is financed by the government. At present, we have six (6) regional blood centres, twenty (18) local blood banks with different functions. Seventeen blood banks, as hospital blood bank belonging to the service, have two main responsibilities; one is the collection of whole blood and the second is controlling of patient’s samples. Virus- and blood group serological examinations of donor samples are screened and preparation of blood products are processed in seven blood banks. However, clinical transfusiological examinations are carried out in each of our Blood Banks (BBs) (Fig. 1). The Headquarters of HNBTS directs and co-ordinates blood supply, distribution and

transportation of blood products, in connection with blood banks and hospitals. To cover the needs of 10Æ1 million Hungarians, approximately 450 000 donations take place yearly, which means that each donor is bled 1Æ6 times a year on average (Fig. 2). In 2007, the collection rate of whole blood was 41Æ79 ⁄ 1000 population. Issued products ⁄ 1000 population RBCs 39Æ24 PLTs 13Æ68 FFP 8Æ12 • In the whole country, the blood supply has been well organized by the HNBTS; the dispatch department in the Headquarters is responsible for it. • There is a common standard for the evaluation of blood donor suitability and for testing infectious markers which are compatible with EU standards (98 ⁄ 463 ⁄ EC, 2002 ⁄ 98 ⁄ EC, 2004 ⁄ 33 ⁄ EC, 2005 ⁄ 61 ⁄ EC, 2005 ⁄ 62 ⁄ EC). Principles set in the Council of Europe Recommendation 95 Guide to the preparation, use and quality assurance of blood components have been applied since 1993. The shelf life of the different products that our system produces are as follows: Red blood cells is 35 days, platelet concentrates is 5 days and FFP is 2 years. • The estimated outdate rate is < 3%. We do not have correct data from the hospitals.

Question 2 To date, we have not been able to prepare and transfuse pathogen-inactivated products. Instead of CMV-negative products, we use leucocyte-depleted (filtered) blood products, because the CMV-positive rate is higher than 70% in the population. The irradiated blood products are used for transfusion for more than 8% of red blood cells, 1Æ30% of platelets and 1–2% of FFP. These products are provided for transfusion of low weight newborns, indicated for patients before and after transplantation, with known or suspected leucocyte antibodies to prevent alloimmunization, etc. These products are issued by the clinician’s requirements.

Question 3 In most situation, the ‘first-in-last-out’ method is used to select the best suitable (fit) products. In the neonatological health care, special attention is given that the product should be as young as possible, in case of RBCs this means a maximum of 5 days. In Hungary, the stocks are hold on three different places: in the blood banks (70% of total amount), in hospital blood banks (20% of total amount) and in hospital departments (10% of total amount). There is a national administration registering the amounts of stocks at

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different locations. The remaining part of blood products are sent to the centre because the ratio of blood donation is higher in the countyside. The national register is responsible for controlling the quality and quantity of the national stocks, co-ordinating of the related logistics and informatics blood supply, distributing of blood products, and organizing the transportation (8000 event) and collaboration between blood banks and hospitals. The blood management tries to influence the hospital supply in a way that only such quantity and types of products should be stored at the hospital blood banks that are essential only for the supply in emergency case. Average age of issued RBCs is < 20 days. The national monitoring of the supply ⁄ day is primary referring to RBCs, regarding the PLTs and FFP the regions are generally selfsufficient.

Question 4 Accordingly we are transfusing with the youngest products, especially regarding the sensitive groups of patients.

Question 5 The average age of the transfused PLTs is 2Æ5 days. In our practice, the apheresis platelets are used in most cases on the day of preparation. These products are dedicated to one patient. At present, we have no ability to examine all the produced PLTs for bacterial contamination, although the PLT storage blood bags used in our system could make it possible for us to extend the storage time for 7 days.

Question 6 The PLTs are used for supply and for development, resulting from the clinicians, otherwise the other influential fact of

51·00 49·83

50·00 49·67 48·97

48·79

49·00

48·67

48·61

48·00 47·00

46·28

45·98

46·00 45·00 44·00

2000

2001

2002

2003

2004

2005

2006

2007

Fig. 2 Donation in Hungary (population 10 100 000). Donation ⁄ 1000 population.

the blood management is the ensuring of the cost effective manufacturing and the delivery conditions, while the most important fact is the support of safe transfusion. K. Barotine-Toth, PhD Hungarian National Blood Transfusion Service 19–21. Karolina street Budapest 1113 Hungary E-mail: [email protected]

R. B. Sawant The blood Transfusion system model in India has been getting organized in the past few years and slowly shifting from its current decentralized system to establishing centralized centres of excellence in the four zones of India. Inventory is moved from one geographic region to another only in the following exceptional and emergency scenarios:

Miskolc Salgótarján

Sopron

Nyíregyháza

Eger

Vác Györ Tatabánya Budapest Péterfy S.

Debrecen

Dél-pest

Szombathely Veszprém

Szolnok

Székesfehérvár

Zalaegerszeg

Kecskemét Békéscsaba Kaposvár

Szekszárd

Szeged Baja

Pécs Fig. 1 Functional structure of the Hungarian National Blood Transfusion Service.

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(unit) 575 000 550 000 525 000 500 000 475 000 450 000 425 000 400 000 375 000 350 000

Prepared RBCs Issued RBCs for transfusion

325 000 300 000

(unit) 450 000

2007

2005

2006

2003

2004

2002

2001

2000

1999

1997

1998

1996

1995

1993

1994

1992

1991

1990

1989

1988

1986

250 000

1987

275 000

Fig. 3 Issued Blood products.

Issued Blood products

400 000 350 000 300 000 250 000

Whole blood RBCs FFP PLT

200 000 150 000 100 000 50 000 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

0

(1) Major natural disasters and terrorist attacks occurring in a particular area leading to sudden increase in demand of blood components. (2) Epidemic outbreaks of infectious diseases such as Dengue, Leptospirosis and Malaria leading to increased platelet demands within a short time span. (3) Transfusion requirements of a ‘Bombay blood group’ patient. On the whole, blood component exchange between blood banks or across regions is not encouraged by the FDA authorities in India to avoid potential discrepancies and confusion due to wide variations in standard practices for blood collection, testing, processing and storage across various cities or regions in the country. Moreover, there is lack of proper temperature-controlled transport facilities in most of the parts of India. Metropolitan cities such as Mumbai have resorted to a solution to this problem by forming a registered body ‘Federation of Mumbai blood banks’, which regularizes and ascertains exchange of excess blood units

Fig. 4 Prepared RBCs and issued for transfusion RBCs.

across blood banks in the city (only after ensuring the adherence to standard quality procedures by these blood banks). Shelf life of various blood products at our blood centre is as follows:

Sr.

Blood product

Shelf life

1 2 3 4 5 6 7 8 9 10

Whole blood Packed red cells (without additive solution) Packed red cells (with additive solution) Platelet concentrate (RDP) Apheresis platelets (SDP) Fresh-frozen plasma (FFP) Cryo precipitate Granulocyte concentrate Plasma-depleted SDP Gamma-irradiated red cells

11

Gamma-irradiated platelets (RDP or SDP)

35 days 35 days 42 days 5 days 5 days 1 year 1 year 24 days 4h 14 days post-gamma irradiation 5 days

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The accurate figures of number of units of each type of product collected annually and the utilization rate of each product, expressed as per 1000 population are not available due to the absence of a single robust data collection system for the above in India. Outdate rates for various blood products at our Hospital:

Outdate rate Component

2006

2007

2008

Overall rates (%) WB (%) PC (%) RDP (%) SDP (%) FFP (%)

20 8 12 18