Professional Documents
Culture Documents
Abstracts Book International Congress of Transfusion Medicine Oradea 2012 March 22 25
Abstracts Book International Congress of Transfusion Medicine Oradea 2012 March 22 25
Transfuzionala;
Volum de rezumate
Oradea, 22 – 25 martie 2012
Abstracts’ Book;
International Congress of Transfusion
Medicine
Oradea, 2012, March 22 – 25
2
Pr 09. The Status of Quality System Implementation in Blood Transfusion Establishments in Republic of
Moldova, Svetlana Cebotari........................................................................................................................ 27
Pr 10. WNV si securitatea transfuzionala: concluzii ale anului 2011, propuneri pentru anul 2012, G
Folléa, R Lieshout , P Hewitt, Wr Mayr (EBA) ......................................................................................... 28
Pr 10. West Nile Virus and blood safety: lessons learnt from 2011 proposals for 2012, G Folléa, R
Lieshout , P Hewitt, Wr Mayr (EBA) ......................................................................................................... 30
Pr 11. Terapia transfuzionala in anemia hemolitica autoimuna: experienta spitalului Universitar Bucuresti,
Corina Posea, Anca Ursachi........................................................................................................................ 31
Pr 11. Transfusion Therapy in Autoimmune Hemolytic Anemia: Bucharest University Hospital Experience,
Corina Posea, Anca Ursachi ........................................................................................................................ 32
Pr 12. Dificultati in implementarea sistemului de hemovigilenta in Spitalul Universitar De Urgenta
Bucuresti, Corina Posea, Anca Ursachi ...................................................................................................... 33
Pr 12. Difficulties in Implementing the Hemovigillance System in the University Hospital Of Bucharest,
Corina Posea, Anca Ursachi ........................................................................................................................ 34
Pr 13. Monitorizarea la nivelul medicinii primare a pacientului care a beneficiat de terapie transfuzionala,
Corina Posea, Anca Ursachi........................................................................................................................ 35
Pr 13. Monitoring of Transfused Patient in Primary Care Medicine, Corina Posea, Anca Ursachi ........... 36
Pr 14. Utilizarea tehnicii conventionale si a tehnicii de aglutinare in coloana pentru efectuarea testelor
pre-transfuzionale in unitatile de transfuzie sanguina din spitale, Gabriela Miricescu............................... 37
Pr 14. The Use of Conventional and Column Agglutination Techniques for Pre-Transfusion Testing in
Blood Transfusion Units of the Hospitals, Gabriela Miricescu .................................................................. 39
Pr 15. Principii generale ale recoltarii prin afereza a celulelor stem periferice. Recoltarea celulelor stem
periferice cu automatul MCS + HAEMONETICS, Gabriela Miricescu..................................................... 41
Pr 15. i selePcni rPrlareneGoi si rePrelePcni lnPP i ere i aennGi aPnnearrPlGb.si selePeGrG lei selePeGrGi
i aPnnearrPloEsHeOTH aei sE Oes Hi +si rePrelePcni lnPP i ere i aennGi errli eaei , Gabriela
Miricescu .................................................................................................................................................... 43
Pr 16. Raportul anual de activitate a unitatilor de transfuzie sanguina din cadrul spitalelor, Simona Parvu
.................................................................................................................................................................... 45
Pr 16. Annual Activity Report of the Hospitals Blood Transfusion Units, Simona Parvu ............................ 46
Pr 17. Standarde şi criterii europene comune pentru inspectia unitatilor de transfuzii sanguine, Simona
Parvu ........................................................................................................................................................... 47
Pr 17. Common European Standards and Criteria for the Inspection of Blood Establishments, Simona
Parvu ........................................................................................................................................................... 49
Pr 18. Strategia Ministerului Sanatatii privind sistemul transfuzional din Romania, Ministru, Dr. Ritli
Ladislau ....................................................................................................................................................... 51
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Pr 18. The Strategy of The Ministry of Health for the Transfusion System in Romania, Minister, Dr. Ritli
Ladislau ....................................................................................................................................................... 53
Pr 19. Implementarea Ord. M.F.P 946/2005 cu modificarile si completarile ulterioare, privind controlul
intern/managerial in Centrele de Transfuzie Sanguina, Sevastiana Bran1, Cristina Stoian2 ...................... 55
Pr 19. Implementation of Ord. Mfp 946/2005 as Amnended and Supplemented, on Internal Control /
Management in Blood, Sevastiana Bran1, Cristina Stoian2 ......................................................................... 57
Pr 20. Controlul intern de calitate in laboratorul de imunohematologie (CTS ŞI unitati de transfuzie din
spital), Victoria Halmagi1 , Cristina Bichis2 .................................................................................................. 59
Pr 20. Internal Quality Control in Immune-Hematology Lab (BTC and Hospital Transfusion Units),
Victoria Halmagi1 , Cristina Bichis2 .............................................................................................................. 60
Pr 21. Formularele aferente activitatii centrelor de transfuzie sanguina şi interfata cu spitalele, Victoria
Halmagi1 , Cristina Bichis2 ........................................................................................................................... 61
Pr 21. Reporting Documents of BTCS and the Interface With Hospitals, Victoria Halmagi1 , Cristina Bichis2
.................................................................................................................................................................... 63
Pr 22. Iradierea produselor sanguine labile, pentru prevenirea riscului post-transfuzional al maladiei
grefonului contra gazdei (PT-GVHD, engl.) La pacientii imuno-deprimati, Jean Gerota ............................ 65
Pr 22. Irradiation of Blood Products: Prevention of the Risk of Post-Transfusion Graft-Versus-Host
Disease (Pt-Gvhd) in Immuno-Depressed Patients , Jean Gerota............................................................... 67
Pr 23. Modele de raportare (formulare) a reactiilor/incidentelor severe transfuzionale (cf OMS 1228);
prezentarea definitiilor de caz, gradelor de severitate, nivelului de imputabilitate; ancheta
transfuzionala, Diana Pelea1, Patricia Marusca2, Ovidiu Burta2.................................................................. 69
Pr 23. Reporting models (documents) for severe transfusion reactions/incidences (cf OMS 1228); cases
definitions, severity degrees, level of imputability; transfusion investigation, Diana Pelea1, Patricia
Marusca2, Ovidiu Burta2 .............................................................................................................................. 70
Pr 24. Formulare aferente activitatii Unitatilor de transfuzie sanguina (UTS), Diana Pelea1, Patricia
Marusca2, Corina Posea3, Olivia Ligia Burta4 ............................................................................................... 71
Pr 24. Documents corresponding to hospital transfusion unit (HTU) activity , Diana Pelea1, Patricia
Marusca2, Corina Posea3, Olivia Ligia Burta4 ............................................................................................... 72
Pr 25. Legislatia aferenta organizarii si functionarii Comisiei de Transfuzie si Hemovigilenta (CTH) si
Unitatii de Transfuzie Sanguina (UTS), Diana Pelea1, Patricia Marusca2, Simona Parvu3 ........................... 73
Pr 25. Current legislation about transfusion and hemovigilance comission (THC) and hospital transfusion
unit (HTU), Diana Pelea1, Patricia Marusca2, Simona Parvu3 ...................................................................... 74
Pr 26. Alianta europeana a sangelui: prezentare, realizari in 2011, proiecte pentru 2012, Gilles Folléa,
Olivia Ligia Burta, Andrei Rosin ................................................................................................................... 76
Pr 26. European Blood Alliance: Presentation, Achievements in 2011, Projects for 2012, Gilles Folléa,
Olivia Ligia Burta, Andrei Rosin ................................................................................................................... 77
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Pr 27. Interconditionarea: fisa postului – program de instruire a cadrelor sanitare medii – evaluarea anuala
a performantelor profesionale, Romulus Roman1, Olivia Ligia Burta1,2 , Radu Iovan2, Patricia Marusca2 78
Pr 27. Interrelation: individual professional responsibility sheet – medical staff training program – annual
evaluation of professional skills, Romulus Roman1, Olivia Ligia Burta1,2 , Radu Iovan2, Patricia Marusca2
.................................................................................................................................................................... 79
Po 01. Tulburari posttransfuzionale ale potasiului si echilibrului acido-bazic, Mir, Hira1, 3, Mir, Hajra2,
3, Ovidiu Burta3, Olivia Ligia Burta3, 4 .................................................................................................... 81
Po 01. Post-Transfusion Potassium- and Acid-Base- Imbalance, Mir, Hira1, 3, Mir, Hajra2, 3, Ovidiu Burta3,
Olivia Ligia Burta3, 4 ................................................................................................................................... 82
Po 02. Hipocalcemia post-transfuzionala, Mir Hira1, 3, Mir Hajra2, 3, Patricia Marusca3,4, Ovidiu
Burta3,4....................................................................................................................................................... 83
Po 02. Post-Transfusion Citrate Toxicity, Mir Hira1, 3, Mir Hajra2, 3, Patricia Marusca3,4, Ovidiu Burta3,4 84
Po 03. Reactia hemolitica acuta si intarziata post-transfuzionala, Ioana Zaha1,2, Olivia Ligia Burta2 ..... 85
Po 03. Acute and Delayed Hemolytic Reactions, Ioana Zaha1,2, Olivia Ligia Burta2 ................................. 86
Po 04. Supraincarcarea circulatorie posttransfuzionala, Andrei Tarsoly1, 2, Romina Crisan1, 2, Olivia Ligia
Burta2, Diana Pelea2 .................................................................................................................................... 87
Po 04. Posttransfusion circulatory overload, Andrei Tarsoly1, 2, Romina Crisan1, 2, Olivia Ligia Burta2,
Diana Pelea2 ................................................................................................................................................ 88
Po 05. Insuficienta respiratorie acuta post-transfuzionala, Carina, Dudas (Petricau)1, 2, Olivia Ligia Burta2
.................................................................................................................................................................... 89
Po 05. Transfusion Related Acute Lung Injury (Trali), Carina, Dudas (Petricau)1, 2, Olivia Ligia Burta2 . 90
Po 06. Boala grefon contra gazda post-transfuzionala, Lavinia Florentina Rad1,2, Olivia Ligia Burta2 ..... 91
Po 06. Transfusion-Associated Graft Versus Host Disease (TA-GVHD), Lavinia Florentina Rad1,2,
Olivia Ligia Burta2 ..................................................................................................................................... 92
Po 07. Reactie alergica usoara (urticarie) in relatie cu terapia transfuzionala, Roxana Burta1, Carina Dudas
(Petricau)1, Sebastian Stanciu1, Olivia Ligia Burta2, Stefan Reikli2 ........................................................... 93
Po 07. Mild Allergic Reaction Transfusion-Related, Roxana Burta1, Carina Dudas (Petricau)1, Sebastian
Stanciu1, Olivia Ligia Burta2, Stefan Reikli2............................................................................................... 94
Po 08. Hemoliza acuta post-transfuzionala mediata non-imun, Paula Dejeu1, Adela Vicas1, Danut Dejeu2,
Razvan Vicas3, Olivia Ligia Burta4 ............................................................................................................. 95
Po 08. Acute Non-Immune Hemolytic Transfusion Reaction, Paula Dejeu1, Adela Vicas1, Danut Dejeu2,
Razvan Vicas3, Olivia Ligia Burta4 ............................................................................................................. 96
Po 09. Reactiafebrila post-transfuzionala, non-hemolitica, Horatiu Burta1, Teo Rif1, Sebastian Heredea1,
Bogdan Leahu1, Catalin Nicolae1, R. Iovan2 .............................................................................................. 97
Po 09. Non-haemolytic immune transfusion reactions (NHTR), Horatiu Burta1, Teo Rif1, Sebastian
Heredea1, Bogdan Leahu1, Catalin Nicolae1, R. Iovan2 ............................................................................. 98
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Po 10. Contaminarea bacteriana, Ioana Szanto1, Ramona Budau1, Olivia Ligia Burta2 ............................. 99
Po 10. Bacterial Contamination, Ioana Szanto1, Ramona Budau1, Olivia Ligia Burta1, 2 ......................... 100
Po 11. Trombocitopenia posttransfuzionala (TPT), Adela Vicas1, Paula Dejeu1, Olivia Ligia Burta2 ..... 101
Po 11. Posttransfusion Purpura (PTP), Adela Vicas1, Paula Dejeu1, Olivia Ligia Burta2......................... 102
Po 12. Reactie alergica severa-soc anafilactic, Nicoleta Marcut1,2, Mirela Florescu3, Catalin Florescu2,
Patricia Marusca2 ...................................................................................................................................... 103
Po 12. Posttransfuzional Severe Allergic Reaction- Anaphylactic Shock, Nicoleta Marcut1,2, Mirela
Florescu3, Catalin Florescu2, Patricia Marusca2 ........................................................................................ 104
po 13. Coagulopatia intravasculara diseminata (CID) post transfuzionala, Romina Crisan1,3, Ingrid Veres2
.................................................................................................................................................................. 105
po 13. Transfusion-Related Disseminated Intravascular Coagulation, Romina Crisan1,3, Ingrid Veres2 106
Po 14. Contaminarea microbiana; agenti infectiosi cu potential de transmitere transfuzionala, Radu
Iovan1, Olivia Ligia Burta2, Bogdan Leahu1,3, Catalin Nicolae1,3............................................................ 107
Po 14. Microbial Contamination, Infectious Agents with Potential Transfusion Transmission, Radu
Iovan1, Olivia Ligia Burta2, Bogdan Leahu1,3, Catalin Nicolae1,3............................................................ 108
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Sesiune prezentari
Presentations Session
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Pr 01. Implicarea medicinii primare in promovarea donarii de sange, la
diferite categorii populationale
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Pr 01. The Role of General Practitioners in Blood Donation Promotion, in
Different Population Categories
Introduction. Primary care providers have an important role in promoting responsible health
behaviour choices and in reducing health inequalities. They can play a crucial role in donor
education, selection and retention. Health promotion and education programmes are proved to be
sustainable and effective when the interventions are accessible, continuous, patient centered and
adapted to community needs.
Objectives. To identify best practices adapted to primary care for building effective and efficient
partnership and collaboration between different health service providers and communities aimed
to recruit and retain safe blood donors.
Methods. We conducted a SWOT analysis about promoting blood donation in primary care in a
group formed of general practitioners, practice nurses, teachers and specialists responsible for
blood donation. Different case studies included areas with good accessibility to the service,
resource poor settings, youth groups, working in teams with other care providers.
Results. We had identified the criteria for the best practice in community centered promotion of
blood donation. Availability of the service, pro-activeness, continuity, inter-professional
collaboration, community participation are amongst the most important features. However,
training of the health care professionals, development of donor education materials, quality
monitoring, adapting of the services to local requirements are also proved to have a key role.
Conclusions. Comprehensive active inclusion strategies of the promotion of blood donation in
primary care will result in improved understanding of voluntary donation, raised community
awareness, change in attitudes and behaviours, patient safety and donor safety.
Keywords. Primary Care, Education, Blood Donation, Responsible and Self Conscious, Healthy
Behaviour
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Pr 02. Prezentarea brosurii: „ Statusul current si viitor al strategiilor din
domeniul Securitatii Transfuzionale in Medicina de Urgenta si Circumstante
Speciale”,
1
European Directorate for Quality of MedicineDQM- CoE
2
WHO Regional Office for Europe
3
Reteaua de Sanatate pentru Sud-Estul Europei; presedinte al departamentului pentru integrare
europeana proiect securitatea sangelui (SEEHN BS)
4
Reteaua de Sanatate pentru Sud-Estul Europei –Manager Regional pe proiectul Securitatea
Sangelui
5
Alianta Europeana a Sangelui
Introducere. Situatiile definite ca si situatii de urgenta in serviciile transfuzionale, sunt din ce in
ce mai frecvente, datorate cresterii frecventei patologiei induse de situatii critice imprevizibile
(cauze naturale, accidente, „arma biologica”) care pot afecta negativ procedurile operationale
prespital si spital, ale terapiei transfuzionale (legate de infrastructura, personal, echipamente,
facilitati).
Scop. Capacitatea unei institutii medicale, de a raspunde eficient in situatii de urgenta si
circumstante speciale, impune dezvoltarea unui sistem coordonat de activitati specifice,
secventiale ale fiecarei verigi implicate in terapia transfuzionala. Planurile nationale de
contingenta trebuiesc concepute si validate, in asa maniera incat elementul „ surpriza” sa fie
minimal.
Material si metoda. In cadrul Retelei de Sanatate pe Sud-Estul Europei, s-a identificat
necesitatea acordarii importantei cuvenite securitatii transfuzionale, astfel ca in cadrul proiectului
destinat acestui obiectiv, s-a derulat activitatea „Cresterea disponibilitatii de sange si produse
sanguine securizate in urgente medicale si circumstante speciale” (“Increasing the transnational
availability of safe blood for medical emergencies and special circumstances”) in cursul lunii
iunie 2011, la Oradea. Activitatea a fost sustinuta atat financiar cat si profesional de structuri
internationale (CoE, OMS, Slovenia) si de expertii lor in domeniu. Echipele multidisciplinare de
specialisti din cele 9 tari partenere, au s-au implicat activ in dezvoltarea unui cadru comun, de la
care sa se dezvolte programe nationale, cu targetul final: autosuficienta cu sange si produse
sanguine securizate, in situatii speciale.
10
Concluzii. Pe baza completarii chestionarelor personalizate de evaluare si a rapoartelor nationale
(draft conceput cu ocazia derularii activitatii) s-a identificat specificul fiecarei natiuni, cu
punctele slabe si puntele tari, toate stand la baza dezvoltarii strategiei viitoare pentru atingerea
obiectivului propus. Punctul final al activitatii, il constituie tiparirea unei brosuri, ca si material
de referinta, cu titlul „ Statusul curent si viitor al strategiilor din domeniul Securitatii
Transfuzionale in Medicina de Urgenta si Circumstante Speciale”, care prezinta intr-o maniera
profesionista, datele obtinute in cadrul acestei activitati.
Cuvinte cheie. Situatii de urgenta, circumstante speciale, securitate transfuzionala, planuri de
contingenta
11
Pr 02 The Booklet „South-Eastern Europe Health Network Current Status
and Future Strategies in Safe Blood and Blood Components
Transnational Availability for Medical Emergencies and Special
Circumstances, in South Eastern Europe” Presentation,
1
European Directorate for Quality of MedicineDQM- CoE
2
WHO Regional Office for Europe
3
South Eastern Europe Health Network (SEEHN), Chair Head, Department for European
Integration
4
SEEHN BS – Regional Manager of Blood Safety Project
5
European Blood Alliance (EBA)
Introduction. The defined conditions as „medical emergencies, and special circumstances are
increasing in frequency, due to higher incidence of pathologies caused by unpredictable
situations (such as natural causes, accidents, „ biological weapons”) being able to affect in a
negative way the pre-hospital and hospital operational procedures of transfusion therapy (eg
infrastructure, staff, equipment, other facilities).
Aim. The capacity of a medical institution to act in an efficient manner in emergency situations
and special circumstances, imposes the development of a coordinated system of specific
activities, sequentially for each ring of the transfusion therapy chain.the national contingency
plans, should be elaborated and validated in due time, in order to avoind as much as possible the
„surprise” reaction.
Material and method. As part of SEEHN project, was identified the necessity to pay attention
to transfusion safety, thus as part of the entire project, was developed and ruled the entitled
„Increasing the transnational availability of safe blood for medical emergencies and special
circumstances” last June, in Oradea. The activity was supported financial by European
Organizations (CoE, WHO, Slovenian Authorities), and professional with experts in transfusion
domain. The multidisciplinary teams from the 9 countries, were actively involved in developing
a common frame, as reference for national programs, having as final target: self-sufficiency with
safety blood and blood products in certain condition.
12
Conclusions. Based on data reported on personalized questionnaire, and national report (drafted
during June activity) completion, was identificed the specificity of each nation, with afferent
weak and strong points, all these representing references for future strategies, in order to get to
the main objective. The final moment of the last June activity is the publish of a booklet entitled
„South-Eastern Europe Health Network Current status and future strategies in Safe Blood and
Blood Components Transnational Availability for Medical Emergencies and Special
Circumstances, in South Eastern Europe” where are presented in a professional manner, all
collected and interpreted data.
Key words. Emergency Situations, Special Circumstances, Transfusion safety, Contingence
Plans
13
Pr 03. Catalogul produselor sanguine furnizate la nivelul centrelor de
transfuzie sanguine; perspective
Introducere. Unul dintre obiectivele primordiale ale activitatii centrelor de transfuzie, este
livrarea unui produs de calitate biologica maxima si cu risc rezidual infectios minim.
Scop. Prezentarea produselor destinate terapeuiei transfuzionale (atat labile cat si stabile), cu
propunerea configurarii unei brosuri personalizate (catalog) intr-o maniera atractiva.
Concluzie. Necesitatea editarii catalogului de produse, care sa fie accesibil atat in forma
electronica cat si pe suport de hartie, la nivelul institutiilor medicale implicate in terapia
transfuzionala.
14
Pr 03. The Catalog of Blood Components, Issued by Romanian Transfusion
Service; Future Trends
Aim. Will be presented the products (both labile and stable) with transfusion administration
purpose, along a proposal about the configuration in a very „ friendly” way of a personalized
catalog (booklet).
Material and methods. Shortly will be presented the history of blood products panel, during the
last 2 decades, then sequentially each product, with afferent indications and biological proprieties
. Will be mentioned other therapeutical products, lacking/or limited used on Romanian market,
due either the technical incapacity, or high financial involvement, but with future practical
solutions for our transfusion therapeutic market, for alliniation with European standards.
Conclusion. Is imposed by practical and eficacy reasons, to be configurated and issued (both
electronic and paper support) then distributed to any medical institution involved in transfusion
therapy.
15
Pr 04. Rolul colectei mobile in asigurarea auto-suficientei in terapia
transfuzionala
Scop. Prin prezentarea de fata se doreste detalierea aspectelor specifice ale colectei mobile cat si
maniera in care aceasta activitate, motiveaza includerea ei in politica si strategia Centrului de
Transfuzie Sanguina din Oradea.
Concluzii. Existenta unei politici de promovare atat la nivel de centru cat si la nivel de teritoriu a
actului donarii, responsabilizarea si devotamentul cadrelor medicale implicate in aceasta
activitate, flexibilitatea managementului de varf, avand capacitatea corectarii evolutiilor
nefavorabile, dovedeste ca una dintre solutiile fiabile ale auto-suficientei este colecta mobila.
16
Pr 04. The Role of Mobile Collection in Self-SufficiencyiIn Transfusion
Therapy
Introduction. Blood and blood products mobile collection, can be a relevant activity, with
favorable impact upon self-sufficiency in transfusion medicine.
Aim. The current presentation is configurated to detail the specific respects of mobile collection
activity, and the motivation to be part of the politics and strategy of Blood Transfusion Center of
Oradea.
Material and method. Were used the recorded data from the reporting sheets of the medical
activity, during 2007-2011. For population the references for Bihor county, the information was
got from County Statistical Agency. According to selected criteria, the mobile collection was
assessed according to geographical distribution, the number of blood donors, gender, age and
blood donors’ categories.
Results. The sequential analyze of mobile collection activity, base don already presented criteria,
showed that the trend is similar with that of fixed collection activity (performed at Blood
Transfusion Center Oradea) meaning: progressive decrease of blood donors’ age average, the
rate of new blood donors’ category was variable, but mainly representated by males. The ratio
fixed collection vs mobile collection, shows a ondulant evolution along the studied period.
Conclusions. The existence of blood donation promotion policy (both in the main city, and
different regions of the county) the responsibility and devotion of medical staff, involved in
blood collection activity, a flexible top-managent able to correct any unfavorable evolution.
prove that one of the most reliable self-sufficiency status, is mobile collection.
17
Pr 05. Evaluarea activitatii retelei nationale de transfuzie din Romania, pe
anul 2011
Andrei Rosin
18
Pr 05. The Activity Evaluation of The Romanian National Transfusion
Network, in 2011
Andrei Rosin
Introduction. The evaluation of activity, is a major criterion for future strategy of the Romanian
National Transfusion Network, being presented from both quantitative and qualitative respects.
Aim. Annual evaluation gives a professional opportunity to monitor the specific activity of blood
transfusion centers, and to structure the future activities (promotion, action, correction),
according to certain National/European priorities.
Material and method. Based on the standardized reporting document (about the medical
activity) issued by National Institute of Transfusion Medicine, are sequentially presented and
discussed the reported data about each blood transfusion activity, projected to national level, but
taking in consideration the European context, as well.
Results. From the quantitative point of view, is noticed a diminish (about 25%) in comparison to
2010, but had be taken into account certain objective conditions which limited the activitiy. The
main diminish is noticed al the level of larger blood centers, partly motivated by the insufficient
mobile collection activity, partly by the increased number of new blood donors, implicit the
higher number of rejected blood units. From qualitative point of view, is reported a non-
concordance between reagents consumption and the total number of collected blood and blood
products units.
Conclusions. Based on these data, was noticed that the standard protocols for blood donations,
are not entirely respected, for example sometime is preferred a total blood count, instead of only
Hb level to be performed, this leads to impossibility the blood check to be repeted in other blood
transfusion centers. Similarly, not always can be proven the corelation between reagents usage
for viral markers and the number of collected blood and blood products units. A very important
positive respect, is the increase of blood products quality, due to much higher separation rate,
than in 2010. Is obvious the necessity to implement certain measures in order to increase the
collection efficacy, the blood products quality and unitary working protocols.
Key words. Evaluation, Qualitative, Quantitative, Unitary Working Protocols
19
Pr 06. Evaluarea unitatilor de transfuzie sanguina din spitale (UTS) in
conformitate cu Ord. Msp nr. 1224/2006 la nivelul judetului Bihor in anul
2011
1
Serviciul de Control in Sanatate Publica Bihor, Directia de Sanatate Publica Bihor, Romania
2
Directia de Sanatate Publica Bihor, Romania
20
legislatiei sanitare privind autorizarea UTS din spitale la realitatea actuala, conform directivelor
europene.
Cuvinte cheie. UTS, inspectie, autorizare
1
Redactor sef Revista Medic.ro
2
Product Division Manager, Versa Puls Media
Introducere. Profesionistii din sistemul sanitar au nevoie constanta de informatie de ultima ora,
de calitate, din surse sigure.
Scop. In acelasi timp, educatia medicala continua constituie nu numai o necesitate dar si o
obligatie a medicului pentru a oferi, la randul sau, servicii de cea mai buna calitate.
22
Pr 07. Continuous Medical Education – Milestone in Professional
Development in Transfusion Medicine (E-Learning Model)
1
Editor-in-chief Medic.ro
2
Product Division Manager, Versa Puls Media
Introduction. Healthcare professionals need constant cutting edge quality information from
reliable sources.
Aim. At the same time, continuing medical education is not only a necessity but an obligation for
the physician to provide, in turn, best quality services.
Material and method. Quantitative research conducted in 2009 through questionnaires on a
sample of 3,500 family physicians showed that family physicians need specialized and up-to-
date medical information for their professional development. Also, according to a quantitative
research study conducted by specialized telemarketing companies on a sample of 750 family
physicians in October 2009, it was found that over 52.3% of family physicians are interested in
starting a continuing medical education program offered by a remote specialist medical journal.
Results. As a result, in 2010 and 2011, the magazine Medic.ro promoted continuing professional
education courses at a distance. These courses were subsequently evaluated as a method of
continuous professional training. Also, were subsequently implemented medical courses e-
learning for the other medical specialties.
Conclusions: The research conducted to evaluate the courses, have shown that physicians have
appreciated it. Also, they considered these courses especially useful for clinical practice. This is
the premise for which we propose the implementation of continuing medical education courses
in transfusion medicine.
Keywords. Continuing Medical Education, Market Research
23
Pr 08. Monitorizarea la nivelul medicinei primare a donatorului depistat cu
markeri microbiologici (virusologici, bacteriologici)
1
Directia de Sanatate Publica Bihor, Romania
2
Centrul de Transfuzie Sanguina, Centrul de Cercetari in Medicina de Inalta
Performanta/FMF/UOradea, Romania
Introducere. Recunoscut fiind riscul rezidual infectios al terapiei transfuzionale, fiecare tara si-
a stabilit un sistem de supraveghere al transfuziilor, care se adreseaza intregului lant: de la
donatorul pana la primitorul de sange. Primii 3 agenti infectiosi, cu implicatii in securitatea
transfuzionala, de ordin social, economic si etic pe care le antreneaza, sunt virusul hepatic B, C si
virusul HIV asupra carora vom insista in prezentarea de fata.
Scop. Prevalenta şi incidenta crescuta a hepatitei virale B In Romania (si in judetul Bihor)
precum şi creşterea incidentei hepatitei C şi HIV/SIDA indica o data in plus, necesitatea
prevenirii transmiterii acestor boli prin actul transfuzional, in primul rand prin eligibilitatea
biologica a donatorului de sange, cat si validarea produselor sanguine administrate. Rolul
monitorizarii integrate a donatorului de sange este atat la nivelul centrelor de transfuzie, la
nivelul medicinei primare, cat si al Compartimentului de Epidemiologie din cadrul DSP, cu rol
de liant si coordonator al sistemului de supraveghere ce se doreste cat mai performant.
Material si metoda. Este prezentat modelul sistemului de supraveghere si de monitorizare a
donatorilor, care functioneaza la nivelul judetului Bihor, formularele utilizate, sistemul
informational, cu datele aferente perioadei 2007 – 2011 si anume, indicatorii de evaluare anuali:
numar total donatori monitorizati, numar donatori pe tip de donare, numar si rata de donatori
diagnosticati cu hepatita B, C, HIV, pe tip de donare, numar si rata de donatori pozitivi anuntati
medicului de familie, numarul de persoane imunizate impotriva hepatitei B la nivelul DSP din
randul contactilor cazurilor de hepatita cronica B, numar total de purtatori HIV pozitivi care intra
in sistemul de evaluare si tratament HIV/ SIDA.
Concluzie. Monitorizarea donatorilor de sange, la nivelul retelei de medicina primara este una
dintre masurile de scadere a morbiditatii hepatitei B, C, HIV/SIDA, lues, pe de alta parte,
donatorii diagnosticati intra In sistemele de supraveghere şi tratament specifice fiecareia dintre
aceste patologii, fiind necesare sesiuni periodice de instruire pe aceste domenii de interes. In
plus, este necesara standardizarea la nivel national a sistemelor de monitorizare pentru printr-o
evaluare eficienta si implicarea intr-o maniera cat mai activa a medicului de familie.
Cuvinte cheie. Risc rezidual infectios, sistem de supraveghere, medic de familie
24
Pr 08. The Category of Blood Donors with Positive Microbial Markers
(Viruses, Bacteria) Monitorized By The General Practitioner
1
Public Health Agency Bihor, Romania
2
Blood Transfusion Center, High Performance Medical Research Center, Faculty of Medicine
and Pharmacy, University of Oradea, Romania
Introduction. Being recognized the residual infectious risk of transfusion therapy, each country
developed a surveillance system of transfusion activity, adressed to the entire chain: starting with
the blood donor and ending with the recipient. The first 3 infectious agents, involved in blood
safety, with important social, economic and ethic impact, are represented by: hepatitis virus type
B, C and HIV, the presentation being targeted on these.
Aim. The high prevalence and incidence of B hepatitis in Romania (also in Bihor county) as well
as the higher incidence of C hepatitis and HIV/AIDS, underline again, the necessity to prevent
transfusion transmission of the mentioned viral agents, mainly due to blood donor biologic
eligibility and blood product validation criteria. The role of integrated monitorization of blood
donors, belongs to medical staff of blood transfusion center, to general practitioner and to
Epidemiology Dept. of Public Health Agency, the last as a link and coordinator for all interested
parts to develop an efficient surveillance system.
Material and method. Sequentially is presented the blood donor surveillance system which
functions in Bihor county, also the documents, the IT system; there are reported the collected
annual data during 2007-2011, such as: the total number of monitorized blood donors, according
to blood donor category, the number and rate of blood donors diagnosed with B, C hepatitis, HIV
sero-positive, the number and rate of diagnosed blood donors reported to the general practitioner,
the number of contact individuals immunized against B hepatitis, the total number of the carriers
HIV positive, as part of the HIV/AIDS evaluation and treatment.
Conclusion. The monitorization of blood donors by general practitioner, is one of the most
important measure to decrease the morbidity of B, C hepatitis, HIV/AIDS, lues, on the other
hand the diagnosed blood donors are admitted in specific surveillance and treatment for each
pathology, thus is necessary to be organized training sessions about the domains of interest. Also
is important to exist a national standardization of the monitoring system, for an efficient
evaluation and a more active involvement of the general practitioner.
Key words. Infectious Residual Risk, Surveillance System, General Practitioner
25
Pr 09. Implementarea sistemului de calitate in centrele de transfuzie din
Republica Moldova
Svetlana Cebotari
Centrul National de Transfuzie a Sangelui Chisinau, Republica Moldova
26
Cuvinte cheie. Management, strategie, obiective operationale
Svetlana Cebotari
Results. The essential criteria in order to implement and assure the quality
management in BTCs, noticed during the last 5 years, have permanent caracter,
and are listed below:
total engagement (firm attitude) and coordination from the side of top-
management
institutional well communication system
proper repartition of administrative and financial resources
staff training schedule
the continuous and conscious involvement of the staff
managerial and organization stability of the institution
the implementation of quality system needs to be monitored
Conclusion. The adoption of a quality management system in Moldavian BTCs, is
mainly a strategic decision of the top-management. The project, the
implementation and the maintenance of the quality management, are influenced by
27
the specific objectives, by the volume of issued blood products, by used processes,
by the institution size and structure.
Introducere. Unul dintre domeniile de interes ale EBA, este monitorizarea etiologiilor
infectioase care amprenteaza medicina transfuzionala.
Scopul. Unul dintre agentii infectiosi cu relevanta in politicile de securitate transfuzionala, este
Virusul West Nile; prezentarea de fata insista asupra elementelor majore a acestei patologii, in
ceea ce priveste schimbul informatiilor, testele performante de laborator, aspect legate de
evolutia sezoniera. Toate aceste date, au la baza lectiile invatate anterior (cu anumite aspect ce
trebuiesc reconsiderate) si obiectivele pentru anul 2012, in ceea ce priveste orientarea si luarea
deciziilor corecte, armonizarea in decizii, cu ajutorul nemijlocit al expertilor EBAEID Monitor.
Material si metode. In ciuda utilizarii unpr metode specific, cum sunt : “hartile saptamanale”,
liste de distributie, tabele de raportare, toate conditionate de momentul raportarii (in timp si
simultan) s-a dovedit persistenta confuziei, neclaritati legate de efectuarea/implementarea NAT
(Nucleic Acid Amplification Technique) cat si date inregistrate variat, de la nivelul celor 28 de
tari raportoare.
Concluzii. Este necesar sa se clarifice atat definitiile (de exemplu a ariei afectate, a ariei in care
continua transmiterea virusului WN la oameni) sa se moduleze evaluarile riscului cu scopul de a
atinge beneficiile previzionate, recunoscandu-se importanta lor in securitatea transfuzionala atat
a donatorului cat si la primitorului de sange. Toate aceste aspect impun existent unei colaborari
profesioniste intre institutiile medicale, bazata pe interdisciplinaritate (o echipa complexa
interdisciplinara, compusa din: epidemiolog, infectionist, microbiology, transfuziolog).
28
29
Pr 10. West Nile Virus and blood safety: lessons learnt from 2011
proposals for 2012
Aim. One the infectious agents, which fingerprints the blood safety policies, is WNV; the
presentation insists on main respects of this pathology, regarding information exchange,
performant lab tests to be performed, seasonal reasons. All these are based on learnt lessons
(with some respects which should be reconsider) and future objectives for the WNV 2012
guidance, regarding decision making and harmonization in decisions, with the help of EBAEID
Monitor experts.
Material and methods. Despite of using specific tools, such as ´weekly maps´, distribution lists,
reporting table, conditioned by the manner of working (time and simultaneous) were still noticed
confusions, un-clarity in NAT implementation, and variable reported data from the 28 countries
surveyed and assessed.
Conclusions. Is necessary to clarify the definitions (such as affected area, area with ongoing
transmission of WNV to humans) to modulate the risk assessment, in order to get the expected
benefits, being recognized in both donor and recipient safety, by preventing a potential threat on
blood supply. All these impose the professional collaboration between medical institutions,
based on interdisciplinary approach (a complex team of experts, composed of epidemiologist,
infectionist, microbiologist, clinician, transfusiologist).
30
Pr 11. Terapia transfuzionala in anemia hemolitica autoimuna: experienta
spitalului Universitar Bucuresti
31
Pr 11. Transfusion Therapy in Autoimmune Hemolytic Anemia:
Bucharest University Hospital Experience
32
Pr 12. Dificultati in implementarea sistemului de hemovigilenta in Spitalul
Universitar De Urgenta Bucuresti
33
Pr 12. Difficulties in Implementing the Hemovigillance System in the
University Hospital Of Bucharest
34
Pr 13. Monitorizarea la nivelul medicinii primare a pacientului care a
beneficiat de terapie transfuzionala
35
Pr 13. Monitoring of Transfused Patient in Primary Care Medicine
36
Pr 14. Utilizarea tehnicii conventionale si a tehnicii de aglutinare in coloana
pentru efectuarea testelor pre-transfuzionale in unitatile de transfuzie
sanguina din spitale
Gabriela Miricescu
Hemarom, Bucuresti
Scop. Testarea pre- transfuzionala din Unitatile de Transfuzie Sanguina din Spitale presupune
determinarea la primitor, prin teste de aglutinare directa si indirecta, In tehnica conventionala
si/sau In tehnica de aglutinare In coloana de gel, a urmatoarelor elemente:
- depistarea anticorpilor iregulari: testarea serului pacientului fata de eritrocite test pentru
Depistarea anticorpilor iregulari este mai sensibila si mai fiabila decat proba de compatibilitate
majora. Din aceasta cauza In practica imuno -hematolologica internationala, se recomanda
efectuarea depistarii anticorpilor iregulari pentru toti primitorii. Datorita sensibilitatii si
specificitatii ,Testul Coombs Indirect (TCI) cu eritrocite diluate In solutie LISS, este considerat a
fi mai adecvat pentru depistarea anticorpilor cu semnificatie clinica potentiala, In conditiile In
care tehnica de aglutinare In coloana s-a demonstrat a fi o tehnica simpla, rapida si fiabila. Testul
enzimatic In doua etape poate fi utilizat ca un test complementar. Includerea In procedurile de
37
testare pre-transfuzionala a TCI efectuat In tehnica de aglutinare In coloana de gel, este
considerata cea mai importanta componenta de securitate pentru depistarea anticorpilor iregulari,
dar mai ales pentru proba de compatibilitate majora.
Prin controlul acestor variabile, In tehnica de aglutinare In coloana de gel testarea devine mai
simpla, avand o mai buna reproductibilitate si fiabilitate a rezultatelor. Exista un raport mai bun
Intre sensibilitate si specificitate si confera multiple avantaje legate de absenta etapei de spalare
din TCI, standardizarea dilutiilor eritrocitare si a volumelor de pipetare. Rezultatele sunt usor de
citit si interpretat, fiind stabile cel putin 24 de ore.
Concluzie. Este necesara stabilirea unui protocol standard pentru testarea pre-transfuzionala de
rutina In Unitatile de Transfuzie Sanguina din Spitale, care sa defineasca elementele obligatorii
ale testarii si procedurile ce trebuie adoptate pentru realizarea lor, precizand testele de aglutinare
directa si indirecta necesare pentru fiecare element de testare si reactivii adecvati, si In acelasi
timp tehnicile de aglutinare ce pot fi utilizate In practica de rutina: conventionala , In coloana de
gel sau alte categorii.
38
Pr 14. The Use of Conventional and Column Agglutination Techniques for
Pre-Transfusion Testing in Blood Transfusion Units of the Hospitals
Gabriela Miricescu
Hemarom, Bucharest
Introduction. The goal of pre-transfusion testing is to ensure ABO compatibility between the
donor and the recipient and should detect the most clinically significant red cell antibodies that
will react with donor's red cells causing hemolytic post-transfusion reactions. Natural antibodies
Anti-A and Anti-B are always regarded to be of clinical significance. With few exceptions, red
cell antibodies potentially clinically significant, are those which are reactive in the indirect anti-
globulin test (IAT), performed at 37°C, habitually immune IgG antibodies.
Purpose. Pre-transfusion testing in the Blood Transfusion Units of the Hospitals presume
determination to the recipient, by direct and indirect agglutination tests, usually in conventional
or gel column agglutination technique, of the following elements:
- the ABO (forward and reverse testing) and Rh (D) blood group
- the antibody screening: testing the patient‘s serum against test red cells, for detection of red
cell immune antibodies, clinically significant
- the major cross-match - testing the recipient’s serum against donor’s red cells, to detect
potential incompatibilities.
The antibody screening may be more sensitive and reliable than major cross-match. Therefore in
the international immune –hematologic practice is recommended that antibody screening to be
performed in all pre- transfusion testing. Indirect anti-globulin test (IAT) using red cells
suspended in LISS solution is considered to be more suitable for the detection of clinically
significant antibodies, because of it’s sensibility and specificity. Column agglutination technique
has been shown to be simple, speedy and reliable. Additional tests, such as two-stage enzyme,
may be used. The inclusion of an IAT performed in gel column agglutination technique is
considered to be the most important feature of safety in pre-transfusion testing, in antibody
screening and particularly in the major cross-match.
39
Alternative techniques, like gel column agglutination technique, attempt to control the
undesirable effects of the washing step, individual reading mode of the reactions, the level of
expertise needed for accurately testing, the unstable endpoint, as well as to optimize pH, ionic
strength, the serum-to-cell ratio and others variables of the conventional technique. By
controlling these variables, in gel column agglutination technique, the testing become easier,
having a better reproducibility and reliability of test results. The gel column agglutination
technique has a better balance of both specificity and sensibility and confers many advantages
related to no need for washing step in IAT, standardization of erythrocyte’s dilutions and
pipetting volumes. It provides a clear, easy to read and stable endpoint of reaction and gel cards
can be read with accuracy for at least 24 hours after testing.
Conclusion. A guideline for standard pre-transfusions testing in the Blood Transfusion Units of
the Hospitals should be established, in order to define the mandatory elements of pre-transfusion
testing, the procedures that should be adopted for running them, recommended tests of direct or
indirect agglutination for each element of testing and the suitable reagents, alongside the
recommended techniques of agglutination to be use: conventional, column agglutination or
others.
40
Pr 15. Principii generale ale recoltarii prin afereza a celulelor stem
periferice. Recoltarea celulelor stem periferice cu automatul MCS +
HAEMONETICS
Gabriela Miricescu
Hemarom, Bucuresti
Introducere. Grefarea de celule stem periferice (CSP) la pacientii care au primit tratament
mieloablativ, antreneaza o reconstituire hematologica optima si mai rapida decat grefarea de
maduva osoasa, cu mai putine zile de neutropenie si trombocitopenie. Recoltarea CSP se face
prin afereza si poate fi de tip autolog la pacient sau allogenic la donatorul sanatos.
41
reacPei ePPae nPci cPei nli ln cPii .scri eei rellPnPirci cPnnnnri ei aelrPnsnicPei ecrlc Gri eGrei cc
sreacPei aranni cPei Pi erceci ei aPnearci ci aennnenPPi PlPlnanecrei i ;acnanncri Gri ePPiPc cri ei arannPr
liacPeiGnlriPernPlcreiGeecPcreiePrliaelrPrsnicPeciGcliennrirPrcniclrraPcinncriGriPierceci eiPernPiePr
CnPcrci nleri ePPae nPri ei PeaPnrcPei Grii . PlcrPPnnnri encG ci cPicrci li rPP cParrei Gri ePrrPParrene
+43 eerl ei ei ln cPnni ei aennnei aCi ,ln cPnni leaeGcPi ei ePPae nPri acPei rPecnrei esearncre/
microlitru si de doza tinta stabilita pentru colecta.
Concluzie. Stabilirea unui protocol de mobilizare reusita a CSP din maduva osoasa si
selectionarea unei proceduri eficiente de recoltare prin afereza a CSP, reprezinta parametrii
foarte importanti care contribuie la cresterea calitatii si eficientei terapeutice a procedurii de
grefare a CSP.
42
Pr 15. sCcCPcn rPucouSnCGo n oncce p C eCnnG ecnnCo uccGa rCPuSiCPcb
.sSiCPCGuG niC sSiCPCGuG ecnnCo ucco u i a rCPuSiCPcn oncce p C eCnnG
E EMEnUep sInE snEAs + ep
Gabriela Miricescu
Hemarom, Bucharest
Uc Pceio ucc. PeliPcsri rPi rlei ecrrelrGi dlPi lcdei Peaerde i i )rlea(ePrelePcni cnPP i Gre i aennGi
i rldPndeici, senPccncrrdeirlePcesoptimal and a faster hematological reconstitutionrlcli cPPPdi i
lei aPnnearrPli Psi rleai rGii .li sedePi csGi Psi lenrPPeelrci cl i rlPP cPasrPeelrcdrri ,iPcsr
.)lecnrlsi PlPP(PPicnnPielraii)ecrrelr(eePsPP e icsicelePeGrGicl i csiceicnrPnPiPnGi
Purpose. Oi crcrlrlii rleai PegnrPeGi csuccessful PcrnrscrrPli Psi Gre i aennGi sPP i cPPPdi rlrPi
.lePcnicnPP icl iciessrarelri erlP PnPisisPPiePPic rliicl ieePsPP rliirleiaPnnearrPleePre
43
rleiencrenerii,clrraPcinncre idlPneicnPP icl iciPernPlielcGei nPrliidlrali csrePiaelrPrsnicrrPliPs
lei nPcrrPliPsi.cPeiPernPle irPi rlei PlPPi,PraliencG cicl irlei Pe i aennGiPe crlrliirli rleicPdn
i+43Giln cePiPsiaC' eeel GiPsirlei PlPPi,PleiePPae nPeicl irleiln cePiPsilee e iePPae nPeG
iaennGper micro-liter and the i.ePe esrle ircPierisren iPsiaPnnearrPl
Conclusion. Establishing a protocol for a successful stem cells mobilization sPP i cPPPdirlrPi
liieePrelePcnicnPP icl irleiGenearrPliPsiciessrarelri erlP PnPisisPPiePPiPc rliicl ieePsPP r
cPei aPlGr ePe i dePsi r ePPrclri ecPc erePGi dlrali aPlrPrcnrei rPi ci i ,rlei aPnnearrPli csi celePeGrG
.lrilePigncnrrsicl irlePceenrracniessrarelasiPsirleaiiPcsr
44
Pr 16. Raportul anual de activitate a unitatilor de transfuzie sanguina
din cadrul spitalelor
Simona Parvu
Ministerul Sanatatii, Romania
Introducere. Unul din obiectivele principale pentru atingerea unui nivel ridicat de performanta
al sistem transfuzional este de a asigurarea autosuficienta In sange şi componente sanguine
umane. Acesta poate fi atins prin mai multe directii de actiune printre care se numara şi utilizarea
eficienta de sange şi produse sanguine umane prin asigurarea unei bune colaborari Intre centrele
de transfuzie sanguina teritoriale şi unitatile de transfuzie sanguina din cadrul spitalelor dar şi
prin administarea corecta a acestora.
Scop. In calitate de Stat Membru al Uniunii Europene, Romania are obligatia de a raporta anual
situatia reactiilor adverse şi a incidentelor posttransfuzionale pentru anul anterior. Raportarile din
anii trecuti nu au putut releva situatia reala la nivel national, In lipsa unor proceduri şi a unui
sistem de raportare anuala a activitatii unitatilor de transfuzie sanguina din spitale. Pana In
prezent notificarea In cadrul sistemului de hemovigilenta nu putut functiona corect la nivelul
tuturor institutiilor din sistemului transfuzional, nefiind stabilita o procedura de raportare.Pe de
alta parte art. 13 (1) şi Anexa II din Directiva 2002/98/EC, reglementeaza obligativitatea şi
modalitatea de raportare a activitatii centrelor de transfuzie sanguina, iar Legea nr. 282/2005
privind organizarea activitatii de transfuzie sanguina, donarea de sange şi componente sanguine
de origine umana, precum şi asigurarea calitatii şi securitatii sanitare, In vederea utilizarii lor
terapeutice, prevede elaborarea periodica de rapoarte privind date statistice şi epidemiologice.
Astfel, Incepand cu anul 2011 la initiativa Ministerului Sanatatii, unitatile de transfuzie din
spitale raporteaza activitatea anului precedent dupa un model conceput de expertii din domeniu.
Implementarea raportarii anuale a unitatilor de transfuzie din spitale a urmarit:
45
valoroasa de informatii analiza acestora avand drept scop eficientizarii activitatii unitatilor de
transfuzie sanguina şi corelarea cu activitatea centrelor de transfuzie sanguina teritoriale.
Simona Parvu
Ministry of Health, Romania
Introduction. One of the major objectives to achieve a high level of performance in the
transfusion system is to ensure self-sufficiency in blood and blood components. This can be
achieved by several lines of action, including an efficient use of blood and blood components, as
a result of a good cooperation between territorial blood establishments and hospital blood
transfusion units and the correct administration of these.
Purpose. As a Member State of the European Union, Romania has the annual obligation to
report adverse reactions and the after transfusion incidents for the previous year. Romania last
reports could not reveal a real situation at the national level, in the absence of procedures and a
reporting system set out for the hospital blood transfusion units. Up now the notification within
the framework of the system of haemovigilence could not function properly at levels in the
transfusion system, because there is now reporting procedure established. On the other hand
article 13 (1) and Annex II of Directive 2002/98/EC, provides the reporting activity compulsory
for the blood establishments and the Law no. 282/2005 on organization of the work of blood-
transfusion, donation of blood and blood components of human origin, as well as quality
assurance and safety health, with a view to their therapeutic use, requires the periodic
development of reports on statistical and epidemiological data. So, starting from 2011 on
Ministry of Health initiative, the hospitals blood transfusion units are reporting their activities on
previous year, after a model designed by experts in the field. Annual deployment of the hospitals
blood transfusion units followed:
- The same registration of data at the level of these structures,
- Harmonization of therapeutic activity and the use of blood and blood components,
- The possibility of a drawing up a database which may provide statistical and
epidemiological information that can be used for various reports to the European
Commission,
- Drawing up an complete annual report of activity at the national level that will include all
the institutions of the transfusion system.
Conclusions. The activity reports are a valuable source of information, the aim of their analysis
will be a more efficiently run for the units and a good correlation with the blood establishments
activities. The annual activity report of the hospital blood transfusion units is an important
component of the annual report for the activities of national network of blood transfusion,
developed by the National Institute of Blood Transfusion and a source of data for the European
Commission evaluations.
46
Key words. Self-sufficiency, Annual Report of Activity, Efficacy
Simona Parvu
Introducere. Un obiectiv major In cadrul actiunilor din domeniul sanatatii publice la nivel
national şi european este asigurarea faptului ca "pacientii din Uniunea Europeana care au
indicatie de tratament transfuzional sa primeasca sange In conditii de securitate”.Intrarea In
vigoare a legislatiei Uniunii Europene In domeniul sangelui, pornind de la Directiva 2002/98/CE
şi a cerintele tehnice ale acesteia, a fost urmata de un progres remarcabil In directia asigurarii
furnizarii de sange şi componente sanguine In mod sistematic In conditii de securitate la nivelul
Intregii Europe. Cu toate acestea, extinderea semnificativa a Uniunii Europene a impus ca atentia
responsabililor sa se concentreze asupra necesitatii unor standarde şi criterii pan-europene pentru
inspectia centrelor de transfuzii sanguine – un element esential In punerea In aplicare a bunei
practici.
Scop. In cadrul proiectului European Blood Inspection System (EuBIS), finantat de Comisia
Europeana In baza Cererii de Oferte din anul 2006, şi al Programului acesteia de Sanatate
Publica (2003-2008) privind calitatea şi securitatea sangelui, a fost elaborat şi implementat un
manual (Manualul EuBIS) care cuprinde standarde şi criterii pan-europene pentru inspectia
centrelor de transfuzii sanguine. Acesta este rezultatul unui efort de colaborare a reprezentantilor
institutiilor guvernamentale, centrelor de transfuzii sanguine şi autoritatilor competente din 19
state membre, printre care se numara şi Romania. Astfel, manualul stabileşte:
47
audit/inspectie cu privire la aspectele relevante care trebuie avute In vedere In timpul procesului
de inspectie, incluzand referinte Incrucişate pentru standardele şi criteriile europene comune
referitoare la sistemele de management al calitatii din cadrul centrelor de transfuzii sanguine,
definite In legislatia comunitara. De aceea, manualul va sta la baza unui program de instruire atat
pentru auditorii interni ai centrelor de transfuzii sanguine cat şi pentru inspectorii sanitari ai
Ministerului Sanatatii, acest lucru asigurand aplicarea unitara a standardelor şi criteriilor
europene comune.
-eficientizarea actiunilor de control şi remediere, prin asigurarea unor grile de verificare unitare,
folosite de catre autoritatile competente pentru inspectiile externe.
48
Pr 17. Common European Standards and Criteria for the Inspection of
Blood Establishments
Simona Parvu
Introduction. Ensuring that ‘patients who receive blood transfusion in the European Union are
given safe blood’ is a major objective within the framework of public health on the national and
European level. The entry into force of European Union legislation on blood, based on Directive
2002/98/EC and its technical requirements, has been accompanied by noteworthy progress
towards ensuring the provision of consistently safe blood and blood components across Europe.
The significant expansion of the European Union, however, focused attention on the need to
have common pan- European standards and criteria for the inspection of blood establishments – a
key element in the implementation of good practice.
Goal. Within the European Blood Inspection System (EuBIS) project funded by the European
Commission under its 2006 Call for Proposals and in the framework of its Public Health
Program (2003-2008) addressing the quality and safety of blood, the manual (EuBis Manual) of
pan-European standards and criteria for the inspection of blood establishments was developed
and implemented. It is the result of a collaborative effort of representatives from governmental
institutions, blood establishments and competent authorities of 19 member states, including
Romnaia. The manual sets out:
49
programmes for inspectors of blood establishments and will help to ensure common application
of the European standards and criteria.
Conclusion. The EuBIS manual aims to provide assistance to EU Member States in their
implementation of regulatory requirements set out in Directives 2002/98/EC, 2004/33/EC,
2005/61/EC and 2005/62/EC for:
• blood establishments in need to optimize their quality system and self-inspection process
related to the EU blood directive and to prepare for regulatory inspections by competent
authorities, and
• competent authorities, which wish to use the manual and training guide as a reference for the
implementation process of the European blood legislation related to regulatory inspections.
50
Pr 18. Strategia Ministerului Sanatatii privind sistemul transfuzional din
Romania
51
1. Aplicarea sau extinderea sistemelor de management al calitatii In centrele de transfuzie
sanguina teritoriale şi In unitatile de transfuzie sanguina din spital.
2. Dezvoltarea şi modernizarea infrastructurii In concordanta cu noua organizare a activitatii
de transfuzie sanguina.
3. Dotarea cu echipamente de testare, stocare, etc. de ultima generatie cum ar fi tehnologia
NAT, utila atat In procesul de fractionare a plasmei cat şi In aplicarea masurilor specifice
In situatii speciale (ex. epidemia cu virusul West Nile).
4. Eficientizarea activitatii unitatilor implicate In sistemul national de transfuzie sanguina,
prin implementarea unui sistem unitar informatic de Inregistrare şi dezvoltarea unei baze
de date unice.
5. Initierea procesului de autorizare a institutiilor din sistemul transfuzional conform
cerintelor comunitare.
6. Intarirea capacitatii de control prin organizarea de programe de instruire pentru
inspectorii sanitari de stat precum şi prin elaborarea de norme şi proceduri pentru
desfaşurarea inspectiei In domeniul transfuzional.
Realizarea ambelor obiective presupune formarea de personal şi dimensionarea corecta a
resurselor umane din reteaua de transfuzie sanguina, care In prezent functioneaza sub
normativele legale In vigoare.
De aceea, este absolut necesar implementarea unui sistem clar reglementat şi organizat de
formare profesionala initiala şi continua, prin elaborarea unui program national de instruire In
domeniul transfuziei sanguine pentru personalul medical cu studii superioare, cadre medicale
medii precum şi a altor categorii, care Işi desfaşoara activitatea In domeniul transfuziei sanguine,
cu recunoaşterea competentei In medicina transfuzionala.
Concluzii. In sprijinul aplicarii acestor obiective trebuie sa existe Insa un cadru legislativ cu
norme clare, aplicabile şi In concordanta cu cerintele comunitare, fiind necesara revizuirea şi
reglementarea In regim de urgenta a mai multor acte normative din domeniu. Astfel, Ministerul
Sanatatii a initiat şi elaborat mai mult proiecte legislative care se afla deja pe circuitul de avizare
interna In vederea dezbaterii acestora, precum:
52
Pr 18. The Strategy of The Ministry of Health for the Transfusion System
in Romania
Introduction . The national transfusion system is a strategic sector requiring the Recognition as
part of the emergency medical care system. Ensuring an equivalent level for quality and security
at every stage of the transfusion chain, including the hospital and clinical services is essential in
transfusion therapy.
Purpose. The general framework of the blood transfusion organization and its basic
requirements addressing to the quality and safety of blood are regulated by Law no. 282/2005 on
organization of the work of blood-transfusion, donation of blood and blood components of
human origin, as well as quality assurance and safety health, with a view to their therapeutic
use, transposing Directive 2002/98/EC requirements and partially the Directive 2004/33/EC
requirements. Provisions of Directive 2005/61/EC, Directive 2005/62/EC, and the remaining
requirements of Directive 2004/33/EC are transposed in other legislative acts. Currently
Romania doesn’t have a strategic vision in the field, for medium and long term, to ensure
achieving the performance level of other member states of the European Union in the field of
blood transfusion and integrate these concerns into the national strategies. In this context the
Ministry of Health main objectives in the blood transfusion field are:
1. Stimulating the blood collection by increasing the number of donors, both through the mobile
collection development and the increase of promotion, information, communication and
education for voluntary blood donation.
2. An efficient and effective capitalization of the entire potential of plasmas donation using
fractionation in order to obtain various products used in patients therapy.
Having regard to the amount of plasma produced at national level, it is necessary develop the
capacity for plasma fractionation, by implementing this process or by contracting services with e
result of reduced cost for the obtained products, in the patients benefit.
53
3. Ensuring an efficient use of blood and blood components through a good cooperation between
territorial blood establishments and the hospitals blood transfusion units and the correct
administration of these.
II. Increasing the safety and security level for blood transfusion through:
1. Applying or extending the quality management systems in blood establishments and hospital
blood transfusion units
2. A developed and modernized infrastructure in accordance with the new organization in the
blood transfusion system, such as NAT technology useful both in the fractionation process of
plasmas as well as in special situations when specific measures are applied (e.g. epidemic with
West Nile Virus).
4. The implementation of a recording data system and the development of a unique database
shall provide an efficiently work in all units involved in the national blood transfusion system.
6. Strengthening the control ability by developing rules and procedures for inspections activities
in the blood transfusion field, as well as through the organization of training programs for
inspectors.
III. Achieving both objectives involves a trained personnel and a correct dimensioning of human
resources in the blood transfusion network, which currently operates under legal settings.
Conclusions. An applicable legislative framework, with clear rules and in accordance with the
European Union requirements must support the implementation of these objectives therefore it is
absolutely necessary to revise in a matter of urgency national legal acts in the blood transfusion
field. Thus, the Ministry of Health has initiated and developed some legislative projects that are
already in the approval procedure and for their internal debate, such as:
1. A Government Decision which establishes the organization and operation of the national
blood transfusion system
2. A review of the Health Ministry Order no. 1225/2006 for the approval of the rules concerning
the National Institute of Blood Transfusion, the regional and counties blood establishments, as
well as of the hospitals transfusion units authorization,
54
3. A review of the Health Ministry Order no. 1228/2006 concerning the haemovigilance system,
as well as other projects in order to change some ministry of health legal acts for a correct
transposition of the directives requirements.
1
Centrul Regional de Transfuzie Sanguina Craiova, Romania
2
Centrul Judetean de Transfuzie Sanguina Slobozia, Romania
Scop. Controlul intern este un proces integral realizat de catre conducere si personalul unei
entitati pentru identificarea riscurilor si furnizarea unei asigurari rezonabile ca misiunea entitatii
si obiectivele generale au fost indeplinite.
Metoda. In legislatia din Romania, controlul intern este definit ca reprezentand ansamblul
formelor de control exercitate la nivelul entitatii publice, inclusiv auditul intern, stabilite de
conducere in concordanta cu obiectivele acesteia si cu reglementarile legale, in vederea asigurarii
administrarii fondurilor publice in mod economic, eficient si eficace; acesta include de asemnea
structurile organizatorice, metodele si procedurile.
Controlul intern este format din cinci componente intercorelate : mediul de control, evaluarea
riscurilor, activitatile de control, informarea si comunicarea, monitorizarea.
55
1 Constituirea comisiei de monitorizare, corelarea si indrumarea metodologica a dezvoltarii
sistemului de control intern managerial.
14 Audit intern
Concluzii. Controlul intern este un instrument utilizat de conducere si legat direct de obiectivele
entitatii. Conducerea reprezinta un element important al controlului intern, dar si restul
personalului institutiei joaca roluri la fel de importante in realizarea acestuia.
Cuvinte cheie. Obiective generale, control intern managerial al calitatii, audit intern
56
Pr 19. Implementation of Ord. Mfp 946/2005 as Amnended and
Supplemented, on Internal Control / Management in Blood
Introduction: The Concept of Control The word "control" comes from the latin "against role",
which means checking an act done by a duplicate original. Control the acceptance of semantics is
a constant or periodic review of activities, a situation to track her progress and to take measures
for improvement.
Purpose. Internal control is a process done entirely by an entity's management and staff to
identify risks and provide reasonable assurance that the entity's mission and overall objectives
were met.
Method. In the legislation of Romania, internal control is defined as all forms of control
exercised in the public entity, including internal audit, established by management in accordance
with its objectives and legal regulations, to ensure the administration of public funds in
economic, efficiently and effectively, this includes also cover organizational structures, methods
and procedures.
Internal control components
Internal control consists of five interrelated components: control environment, risk assessment,
control activities, information and communication monitoring.
Stages of implementation of internal control
1 Establishment of Commission monitoring, correlation and methodological guidance of the
internal control system development management.
2 Establishing rules of organization and functioning of the Monitoring Committee, coordination
and methodological guidance of the internal control system development management.
3 Establishment of the monitoring, coordination and methodological guidance of the internal
control system development on requirements management OMFP 946/2005 with subsequent
amendments.
4 Establishment of self-regulation of the internal control system management.
5 Establishment ROF, ROI, organizational, applicable law in the field
6 Implementation of internal control standards management
7 Development Program to develop internal control system of quality management
8 Establish specific objectives and requirements, and organizational structures
57
9 Determination of activities and actions necessary to achieve the objectives for each
organizational structure of the entity
10 Identification of risks and control activities
11 Development of Risk Register
12 Develop operational procedures adapted to work / activities
13 Develop training programs in the field of management control
14 Internal Audit
Conclusion. Internal control is a tool of management and directly related to the entity's
objectives. Leadership is an important element of internal control, and other staff of the
institution plays as important role in its implementation.
Key words. General Objectives, Internal Managerial Control, Internal Audit
58
Pr 20. Controlul intern de calitate in laboratorul de imunohematologie
(CTS ŞI unitati de transfuzie din spital)
1
CTS Deva , Romania
2
CTS Hunedoara, Romania
59
Concluzii. Controlul intern de calitate face parte integranta din sistemul de hemovigilenta şi
securitate transfuzionala.
Cuvinte cheie. Anomalii, remediere, control de calitate
1
BTC Deva , Romania
2
BTC Hunedoara, Romania
60
Pr 21. Formularele aferente activitatii centrelor de transfuzie sanguina
şi interfata cu spitalele
1
CTS Deva , Romania
2
CTS Hunedoara, Romania
61
Verifica de pe avizul de expeditie:
• Locul de plecare
• Destinatie şi destinatar
• continutul de produse şi numarul,
• Conditii de depozitare;
Verifica daca exista concordanta Intre comanda, PSL-urile existente şi cele scrise pe avizul de
expeditie
Transfuziile salveaza vieti, dar pot, de asemenea, ucide. Neglijenta poate avea consecinte grave.
Dupa transfuzie:
• documentele sunt pastrate un exemplar in Foaia de observatie a pacientului , iar celalalt se
returneaza la Unitatea de transfuzie sanguina a spitalului
Trasabilitatea Finalizarea documentelor
Completati cu atentie Formularul de transfuzie , datele pacientului, fara a omite nici o eventuala
reactie posttransfuzionala.
Completeaza formularul de feedback pentru Unitatea de transfuzie din spital si trimite-l
Concluzii. Elementele-cheie pentru siguranta transfuziei sunt:
-O indicatie relevanta;
-Prescriptie corecta;
-Monitorizarea pacientului;
- Raportarea de incidente posttransfuzionale;
-Follow-up (urmarirea pacientului Inainte , In timpul şi dupa transfuzie, urmarirea trasabilitatii).
Cuvinte cheie. Trasabilitatea, feed-back, monitorizare
62
Pr 21. Reporting Documents of BTCS and the Interface With Hospitals
1
BTC Deva , Romania
2
BTC Hunedoara, Romania
Introduction
Organization of blood in hospitals depends on:
a) creation unit of the hospital blood
b) appointment of transfusion and haemovigilance health unit
Commission hospital transfusion and haemovigilance
level monitoring to ensure safety in the hospital transfusion
is responsible for organizing and monitoring the functioning haemovigilance system and
working with the hospital transfusion center territorial adverese transfusion reactions and
analysis
Between BTC and UTS there is agreement on which BTC delivers the BLP's (Blood Labile
Products) validated at the hospital.
Purpose
-We follow all the next steps for taking a blood transfusion from BLP command until the
transfusion.
-Prescription
• Identification of patient name, identification number, sex.
• Identification and signature of doctor.
• Diagnosis.
-Receipt of blood products
Upon arrival of a blood component, check imperatively:
• if the product ordered is the one received.
• consistency of data on the form accompanying the data on blood product
• consistency of patient identity and distribution recorded on the form.
• Consistency between the group performed at the bedside group and the patient.
• Product appearance, integrity, product and store appropriate expiration date.
Check the delivery note:
• Point of departure
• Destination and consignee
63
• content of products and number,
• Storage conditions;
Check if there is consistency between the control, BLPs existing and written notice of shipment
Transfusions save lives but can also kill. Neglect can have serious consequences.
-After the transfusion:
• documents are kept a copy in pacientuli observation sheet and the other unit is returned to the
hospital transfusion
-Complete traceability documents
Complete the form carefully transfusion, patient data, without omitting any possible transfusion
reaction.
Fill out the feedback form to the hospital transfusion unit and send it
Conclusion
Key elements for transfusion safety
A relevant indication;
-Prescription correct;
-Monitoring of the patient;
- Reporting incidents transfusion
-Follow-up (follow the patient before, during and after transfusion, follow traceability).
64
Pr 22. Iradierea produselor sanguine labile, pentru prevenirea riscului
post-transfuzional al maladiei grefonului contra gazdei (PT-GVHD, engl.)
La pacientii imuno-deprimati
Jean Gerota
Introducere. Transfuzia de produse sanguine labile (sange total, masa eritrocitara, trombocite
sau granulocite concentrate) transmite, Impreuna cu celulele terapeutic active, celule limfocitare
imuno-competente (ICC) periculoase, care sunt In mod normal respinse de pacientii cu o stare
imunitara intacta. La unii pacienti grav imuno-compromisi, aceste limfocite pot fi activate şi apoi
prolifereaza. O astfel de grefa involuntara de ICC este responsabila pentru o varianta (post-
transfuzionala) de GVHD, de asemenea cunoscuta ca o complicatie majora a alogrefei de celule
stem medulare.
Scop. Rata de mortalitate extrem de mare datorate aceastei complicatii, creşterea constanta a
indicatiilor şi a pacientilor cu risc, indica necesitatea de prevenire a acestei boli In mod eficient,
cu mijloace uşor de utilizat, accesibile la orice moment. Centrele de Transfuzie, care ofera
produse sofisticate de sange pentru unitatile clinice moderne de Hematologie, trebuie sa
garanteze absenta oricaror ICC mitotical active, care pot fi prezente printre celulele terapeutice
dorite. Doua variabile intervin In special In declanşarea: cantitatea de ICC din produsul sanguin
labil şi stadiul de imunosupresie a primitorului.
Concluzie. Expunerea la anumite doze de radiatii ionizante este cel mai eficient mod de a
preveni maladia post-transfuzionala a grefonului contra gazdei. Doza minima absorbita In
campul de iradiere va fi de 25 Gy, cu nici o zona care sa primeasca mai mult de 50 Gy.
66
Pr 22. Irradiation of Blood Products: Prevention of the Risk of Post-
Transfusion Graft-Versus-Host Disease (Pt-Gvhd) in Immuno-Depressed
Patients
Jean Gerota
Introduction. Transfusion of labile blood products (whole blood, packed red cells, platelets or
granulocytes concentrates) provides, along with the therapeutically active cells, dangerous
lymphocytes called immune-competent (ICC) cells, which are normally rejected in recipients
with unimpaired immunity. In some severely immune-compromised patients, these lymphocytes
may be activated and then proliferate. Such an involuntary “graft” of ICC is responsible for a
variant of Graft-versus-Host Disease (GVHD), also known as a major complication of bone
marrow allograft.
Aim. The extremely high mortality rate of this complication and the constant increase of
indication and of patients at risk, indicate the need for the prevention of this disease by efficient,
easy to use means, accessible at any time. Blood Transfusion Centers, providing sophisticated
blood products for modern hematology care units, must guarantee the absence of all mitotically
active ICC which may be present among the therapeutically desired cells. Two variables
intervene especially in triggering a PT-GVHD: the quantity of ICC injected and the stage of the
recipient’s immunosuppression.
67
evaluation of needs: the irradiation of a few bags can be done in a Radiotherapy Department, on
the contrary, an increasing demand will be done better by a self-contained irradiator.
Conclusion. Exposure to certain doses of ionizing radiations is the most efficient way to prevent
Post-Transfusion Graft-versus-Host Disease. The minimum dose achieved in the entire
irradiation field should be 25 Gy, with no part receiving greater than 50 Gy.
68
Pr 23. Modele de raportare (formulare) a reactiilor/incidentelor severe
transfuzionale (cf OMS 1228); prezentarea definitiilor de caz, gradelor
de severitate, nivelului de imputabilitate; ancheta transfuzionala,
1
Spital Clinic Pelican Oradea, Centrul de Cercetari in Medicina de Inalta
Performanta/FMF/UOradea, Romania
2
Spital Clinic Municipal Oradea, Centrul de Cercetari in Medicina de Inalta
Performanta/FMF/UOradea, Romania
Introducere. Prin Ordinul Nr. 1228/ 2006 se aduce in prim plan asigurarea trasabilitatii, dar si
Regulamentul privind sistemul de inregistrare si raportare in cazul aparitiei de incidente si
reactii adverse severe legate de colecta si administrarea de sange si de componente sanguine
umane. In conformitate cu legislatia actuala, UTS sunt obligate sa raporteze catre Centrul de
Transfuzie Sanguina si Directia de Sanatate Public ajudeteana toate reactiile/efectele nedorite
posttransfuzionale, incepand cu reactiile minore, pana la incidentele severe, in paralel cu
aplicarea primelor masuri terapeutice/corectoare care se impun.
Scop. Autorii isi propun prezentarea si sustinerea importantei supravegherii pacientului atat in
timpul transfuziei cat si in primele ore posttransfuzional, pentru a creste sansa de a se interveni in
timp real in cazul aparitiei reactiilor sau incidentelor legate de administrarea de sange sau
produse din sange.
Metode. Sunt analizate independent toate etapele in care ar putea sa apara astfel de evenimente,
precum si obligatiile personalului implicat in actul transfuzional, cu exemplificarea lor, pe grade
de severitate.
69
Pr 23. Reporting models (documents) for severe transfusion
reactions/incidences (cf OMS 1228); cases definitions, severity degrees,
level of imputability; transfusion investigation
1
Pelican Clinic Hospital Oradea, High Performance Medical Research Center, Faculty of
Medicine and Pharmacy, University of Oradea, Romania
2
Municipal Clinic Hospital Oradea, High Performance Medical Research Center, Faculty of
Medicine and Pharmacy, University of Oradea, Romania
Introduction. Based on MH Order 1228/2006 the traceability assurance is detailed, but also the
regulations regarding the registration and reporting system of severe transfusion adverse
reactions, related to blood and blood products collection and administration. According to
current legislation, the HTU are obliged to report to Blood Transfusion Center (as supplier) and
to Public Health Agency, all unexpected posttransfusion reactions/effects, from the minor ones to
severe incidences, in parallel with appropiate therapeutic/corective measures.
Aim. The authors present and insist on the importance of patient’s surveillance both during the
transfusion therapy and during the first hours portransfusion, having the motivation to increase
the chance of therapeutic support in due time, in case of any reactions/incidents occurence,
related to blood and blood products administration.
Material and method. Independently, are analyzed all the phases which could be part of such
events occurrence, along with the medical staff responsabilities regarding the transfusion
therapy; in order to be more useful there are presented examples, divided according to their
severity.
Conclusion. For recognition of these reactions/incidents related to blood and blood products
administration, the staff should be periodically trained specifically, based on certain work sheet
and procedures; these are devoted to the measures imposed to be followed in such conditions,
using lab data and recorded results (from both patient and transfused samples); the chain
continues with internal investigation to identify the cause and to be established the imputability
level.
70
Key words. Incidents, Adverse Reactions, Transfusion Therapy
1
Spital Clinic Pelican Oradea, Centrul de Cercetari in Medicina de Inalta
Performanta/FMF/UOradea, Romania
2
Spital Clinic Municipal Oradea, Centrul de Cercetari in Medicina de Inalta
Performanta/FMF/UOradea, Romania
3
Spital Universitar de Urgenta Bucuresti, Romania
4
Centrul de Transfuzie Sanguina Oradea, Centrul de Cercetari in Medicina de Inalta
Performanta/FMF/UOradea, Romania
Scop. Autorii isi propun sa prezinte un model pentru un sistem de inregistrari specifice UTS,
astfel incat fiecare etapa sa fie monitorizata, incepand cu documentarea necesitatii terapiei
transfuzionale pentru un pacient pana la momentul posttransfuzional, intr-o maniera usor de
identificat de-a lungul lantului de actiuni, pe baza inregistrarilor efectuate de catre personalul
echipei implicate in transfuzie.
Material si metoda. Este identificat initial sirul al activitatilor din UTS, dupa care sunt
prezentate intr-o succesiune logica si fireasca modele pentru formularele ce pot fi utilizate pentru
inregistrarea tuturor datelor, in acord cu legislatia in vigoare.
71
Cuvinte cheie. Legislatie, trasabilitate, formulare, securitate transfuzionala
1
Pelican Clinic Hospital Oradea, High Performance Medical Research Center, Faculty of
Medicine and Pharmacy, University of Oradea, Romania
2
Municipal Clinic Hospital Oradea, High Performance Medical Research Center, Faculty of
Medicine and Pharmacy, University of Oradea, Romania
3
Emergency Universitar Hospital Bucharest, Romania
4
Blood Transfusion Center Oradea, High Performance Medical Research Center, Faculty of
Medicine and Pharmacy, University of Oradea, Romania
Aim. The authors propose a certain model for specific records al HTU level, in such a manner
that each phase can be monitor, starting with documents based on the needs of transfusion
therapy for the patient, till the postransfusion phase; the monitorization should be done in a very
efficient and logical way along the chain of activities, according to registered data, by the
members of the team involved in transfusion therapy.
Material and mothod. Initially is identified the chain of HTU activities, then are presented in a
logical sequence the models for certain documents, which could be used for all required data
records, in accordance to current legislation.
72
Pr 25. Legislatia aferenta organizarii si functionarii Comisiei de
Transfuzie si Hemovigilenta (CTH) si Unitatii de Transfuzie Sanguina
(UTS)
1
Spital Clinic Pelican Oradea, Centrul de Cercetari in Medicina de Inalta
Performanta/FMF/UOradea, Romania
2
Spital Clinic Municipal Oradea, Centrul de Cercetari in Medicina de Inalta
Performanta/FMF/UOradea, Romania
3
Ministerul Sanatatii Romania – Departamentul de Sanatate Publica si Control
Scop. Autorii propun trecerea in revista a principalelor Ordine MS cu impact asupra activitatii
transfuzionale in spitale.
Material si metoda. Sunt prezentate pe scurt cerintele acestor ordine complementare. Primul
Ordin (nr. 1224/ 9 octombrie 1996), reglementeaza activitatea de transfuzie din spitale, fiind
urmat de un altul care enunta conditiile pentru autorizarea UTS (nr. 1225/9 octombrie 1996).
Ordinul MS Nr. 1228/ 9 octombrie 1996 este cel mai complex: reglementeaza organizarea
sistemului de hemovigilenta, pentru dovedirea trasabilitatii, enuntand in același timp
Regulamentul privind sistemul de inregistrare si raportare in cazul aparitiei de incidente si
reactii adverse; anul urmator, Ordinul MS nr. 1167/2 iulie 2007 aduce completari la Ordinul MS
nr. 1228/ 9 octombrie 1996.
73
implementat si care armonizeaza activitatile, procesele si documentatia intr-un tot unitar capabil
sa demonstreze in permanenta trasabilitatea produselor sanguine.
1
Pelican Clinic Hospital Oradea, High Performance Medical Research Center, Faculty of
Medicine and Pharmacy, University of Oradea, Romania
2
Municipal Clinic Hospital Oradea, High Performance Medical Research Center, Faculty of
Medicine and Pharmacy, University of Oradea, Romania
3
Romanian Ministry of Health – Public Health and health Control Dept
Introduction. During the last 5 years, was noticed a significant re-organization of National
Network according to Transfusion Activity and Hemovigilance System; 1996 represents a
reference in legislative domain on both blood transfusion centers activity (as supplier) and the
HTU (as beneficiar), due to 5 Ministerial Orders, issued in a single day (October 9th).
Aim. The authors’ intention is to present sequentially the main Ministerial Orders, with
significant fingerprint upon transfusion activity at hospital level.
Material and method. There are briefly presented the requirements of the complementary
orders. The 1st one (1224/1996, October 9th) establish the hospital transfusion activity, being
followed by another one where are stated the conditions for HTU authorization (1225/1996,
October 9th). The most complex one is 1228/1996, October 9th, which deals with hemovigilance
system organization, in order to support traceability, along with regulations for
recording/reporting the posttransfusion incidences and adverse reactions; in 1997, July 2nd, was
issued the MH Order nr. 1167, to complete the MH Order 1228/1996, October 9th.
Conclusion. The current legislation succeds to cover the major problems related to transfusion
activity. The MH Order 1132/2007 July, 27th, is focused on quality system, aiming the
activities/processes/documentation harmonization, in such a manner to exist the possibility for
permanent tracing of blood products.
Key words. Legislation, Transfusion and Hemovigilance Comission, Hospital Transfusion Unit
74
75
Pr 26. Alianta europeana a sangelui: prezentare, realizari in 2011,
proiecte pentru 2012
76
Pr 26. European Blood Alliance: Presentation, Achievements in 2011,
Projects for 2012
77
Pr 27. Interconditionarea: fisa postului – program de instruire a cadrelor
sanitare medii – evaluarea anuala a performantelor profesionale,
1
Centrul de Transfuzie Sanguina Oradea
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea
Introducere. Pornind de la Ord. Nr. 1229/01.08.2011, este prezentat si comentat fiecare criteriu
de evaluare, in paralel cu subcriteriile identificate si definite la nivelul Centrului de Transfuzie
Sanguina Oradea.
Scopul. Lucrarea prezinta o abordare originala si specifica a activitatii unui centru de transfuzie,
urmarind adaptarea la cerintele de evaluare anuala a personalului angajat, in conformitate cu
legislatia in vigoare.
Material si metoda. Bazat pe documentul oficial, se insista asupra originalitatii dezvoltarii unui
sistem de evaluare propriu ancorat la realitate, consta in prezentarea unor momente istorice
critice, fiecare caracterizat din punct de vedere al sistemului social, motivatiei si tipologiei
individului. Urmarindu-se atat elementele comune cat si cele specifice momentului raportat, a
fost proiectat un model logic de instruire, conditionat de obiectivul principal, acela de ridicare a
nivelului calitatii actului medical a activitatii transfuzionale prespitalicesti. Curricula de instruire,
alaturi de motivatia ei in cadrul criteriilor de evaluare anuala, este prezentata secvential, pentru
fiecare compartiment de lucru, cu o derulare de subiecte teoretice si practice, de la simplu la
complex, cu monitorizarea evolutiei individuale; structura programului a fost proiectata si
dezvoltata in ultimii 3 ani, din momentul in care s-a recunoscut necesitatea ridicarii la un nivel
superior a calitatii actului medical, intr-un colectiv subdimensionat, in care atat volumul de
munca, cat si complexitatea actului medical creste progresiv.
Concluzii. Sistemul de calitate in medicina transfuzionala este conditie esentiala in asigurarea
securitatii transfuzionale, in conditiile unui management performant. Pornindu-se de la realitatea
romaneasca, se impune gasirea de solutii adaptate la situatia actuala, menite sa dezvolte atat
cunoastintele si abilitatile practice ale personalului unui centru de transfuzie sanguina, cat si
gradul de constientizare a importantei actului medical specific, toate acestea putand fi
cuantificate si monitorizate periodic la nivelul managementului de varf. De asemenea este
imperios necesara configurarea unei scheme la nivel national de instruire a personalului, cu
dezvoltarea unei bibliografii specifice, adaptata fiecarei categorii profesionale.
Cuvinte cheie. Criterii de evaluare, instruire, management performant
78
Pr 27. Interrelation: individual professional responsibility sheet – medical
staff training program – annual evaluation of professional skills,
1
Blood Transfusion Center Oradea , Romania
2
High Performance Medical Research Center/Faculty of Medicine and Pharmacy/University of
Oradea , Romania
Introduction. The reference document is the Romanian Ministry of Health Order, nr.
1229/01.08.2011; each criterion, part of the order, is discussed and divided in subcriteria,
identified and defined in accordance to Oradea Blood Transfusion Center activity.
Aim. The paper presents an original and specific approach of a blood transfusion center activity,
having the purpose to adapt it to annually evaluation criteria of medical staff, according to
current Romanian legislation.
Material and method. Based on the official document, was built The original part of the
evaluation, expressed by the interrelation with current reality, but having as guidelines, the
features of few historic critical moments, from the individual point of view (according to social
system, human motivation and typology). Both common and specific elements were reported
taking into account the certain moment, and based on these, was projected a logical training
schedule, following the main objective, identified as continuous increase of medical act quality
in pre-hospital transfusion activity. Sequentially, is presented the training curricula, along with
the motivation of annually evaluation criteria, according to each department for theoretical and
practical professional achievements, progressively from simple to complex approach, with
periodical monitor of individual evolution, as well. The entire structure of training program, was
developed during last 3 years, the start moment being motivated by obvious necessity to augment
the quality of medical act, in a certain reduced medical collectivity, being characterized by
progressive higher quantity of work and complexity of medical act, as well.
Conclusions. The quality system in transfusion medicine is an essential condition for transfusion
safety assurance, part of a high performance management. Based on Romanian reality, is
tremendous important to search and find specific answers and solutions, having the aims the
development of both knowledge and skills specific to a blood transfusion center medical staff,
and the level of awareness of the importance of medical act, all of these respects being
periodically quantified and monitored, by the top management system. Also, was proved the
necessity to build a national scheme of training sessions adapted on purposes, along with up-to-
date specific bibliography, according to certain professional categories.
79
Key words. Evaluation Criteria, Trening Schedule, Performant Management
Sesiunea postere
Proiectul:
„Reactii transfuzionale”
(mecanisme imunologice/non-imunologice)
Young Doctors/Students
Project:
80
Po 01. Tulburari posttransfuzionale ale potasiului si echilibrului acido-bazic
Introducere. Transfuzia masiva (TM) de sange (administrarea de mai mult decat 10 unitati)
poate afecta atat pH-ul cat si kaliemia recipientului. Acidoza metabolica si hiperkaliemia sunt
modificari tranzitorii si rare, putandu-se dezvolta dupa administrarea rapida de cantitati mari de
sange, care in decursul conservarii pretransfuzie si-au modificat pH-ul (devenind acidic) si
potasiul (devenind hiperkaliemic). Persistenta acidozei si hiperkaliemiei, se datoreaza fie unei
insuficiente hepatice preexistente sau a unei hipoperfuzii tisulare a recipientului, ducand la
acidoza lactica, cu scaderea excretiei renale a potasiului si cu eliberarea potasiului de la nivelul
celulelor anoxice. Pe de alta parte, alcaloza metabolica si hipokaliemia sunt mult mai frecvente,
datorate citratului din sangele conservat, care dupa administrare va fi metabolizat si va fi
convertit in bicarbonat.
Scop. Lucrarea prezinta succint mecanismele fiziopatologice care duc la tulburari ale potasiului
si echilibrului acido-bazic, in conditiile unei transfuzii masive de sange si a atrage atentia asupra
prevenirii, ameliorarii/tratarii acestor complicatii.
Materiale şi metode. Aceste mecanisme sunt ilustrate prin diagrame diferite şi un caz clinic,
selectat pentru a fi cat mai sugestiv acest domeniu de patologie posttransfuzionala.
Concluzie. Tulburarile de potasiu si ale echilibrului acido-bazic pot fi fatale. Fiecare conditie
patologica asociata, exacerbeaza dezechilibrele, ca intr-un ciclu vicios. Este imposibil de a
preveni sau minimaliza aceste dezechilibre, fiind binestiut ca TM se indica In situatii de maxima
urgenta, iar preventia impune utilizarea produselor sanguine spalate. Rezulta importanta
anamnezei corecte pentru a identifica patologiile asociate, In plus, ori de cate ori se indica TM,
ritmul de administrare trebuie sa fie lent, cu monitorizarea extrem de atenta a simptomelor
pacientului, ECG, tensiunii arteriale, şi ionograma care pot ajuta la recunoasterea, tratarea, dar
mai ales preventia dezvoltarii acestei patologii.
Cuvinte cheie. Complicatii transfuzie, hiperpotasemie, acidoza metabolica, hipokaliemie,
alcaloza metabolica
81
Po 01. Post-Transfusion Potassium- and Acid-Base- Imbalance
Introduction. Massive blood transfusion (MT), i.e. more than 10 units, can cause pH and serum
potassium abnormalities. Metabolic acidosis and hyperkalemia are transient and rare, occurring
after a fast transfusion with blood that has become acidic and hyperkalemic during storage.
Persistent acidosis and hyperkalemia, however, occur either due to underlying liver failure or
tissue hypoperfusion, leading to lactic acidosis, diminished renal excretion of Potassium, and
release of Potassium from damaged anoxic cells. On the other hand, metabolic alkalosis and
hypokalemia are more frequent, as citrate from stored blood is metabolized into bicarbonate.
Objective: The purpose of this presentation is to examine the pathophysiological mechanisms
leading to Potassium and Acid-Base disturbances after massive blood transfusions, aiming to
prevent, minimize, and treat these complications.
Materials and Methods. These mechanisms are illustrated using various diagrams and a clinical
case presentation, in order to underline the main aspects to be known by all medical categories
involved in transfusion therapy.
Conclusion. Potassium and acid-base disturbances can be fatal. Each condition exacerbates the
other, often leading to vicious cycle. It is impossible to prevent minimize these reactions by
washing blood products because the vast majority of MTs are conducted in emergency situations.
Good history taking to identify underlying conditions in addition using slower rates of
transfusion and fresher blood while monitoring patient symptoms, ECG, blood pressure, and
electrolyte values can help identify affected individuals for early rectification.
Keywords. Transfusion Complications, Hyperkalemia, Metabolic Acidosis, Hypokalemia,
Metabolic Alkalosis
82
Po 02. Hipocalcemia post-transfuzionala
Introducere. Solutia de citrat avand abilitatea de chelare a ionilor de calciu, are efect anti-
coagulant. In situatii obisnuite, este bine tolerata atat dupa administrarea de sange sau produse
sanguine, cat si dupa procedura de afereza. Cu toate acestea, uneori pot apare efecte adverse, de
exemplu o hipocalcemie severa, care in cazul procedurilor de afereza sunt raportate cu o
frecventa de 0.38%, in conformitate cu Crocco, et al (1997).
Scop. Lucrarea de fata explica etiologia toxicitatii cu solutie de citrate, prezinta din punct de
vedere clinic aceasta patologie, cat si tratamentul (atat postransfuzional cat si postafereza).
Material si metode. Informatiile au fost colectate si coroborate dintr-o varietate de studii, iar
mecanismele fiziopatologice, clinical si diagnosticul sunt ilustrate in imagini si diagrame, intr-o
maniera atractiva, usor de inteles. Cazul clinic vine sa sustina importanta recunoasterii precoce a
patologiei, pentru instituirea terapiei corectoare in timp util.
Concluzie. Deşi dezvoltarea toxicitatii post-transfuzionala cu citrat este rara cu forme clinice
in general usoare, atunci cand este prezenta, nu poate fi ignorata, impunandu-se corectarea
metabolica rapida.
Cuvinte cheie: citrat de toxicitate, hipocalcemie, corectare metabolica
83
Po 02. Post-Transfusion Citrate Toxicity
84
Po 03. Reactia hemolitica acuta si intarziata post-transfuzionala
1
Student, Facultatea de Medicina si Farmacie Oradea, Romania
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea
85
Po 03. Acute and Delayed Hemolytic Reactions
1
Student, Faculty of Medicine and Pharmacy Oradea, Romania
2
High Performance Medical Research Center, Faculty of Medicine and Pharmacy, University of
Oradea
Introduction. Hemolytic transfusion reactions (HTRs) are reactions in which the donor RBCs
are destroyed by antibodies in the recipients` circulation. These can be destroyed in a acute or
delayed manner, after transfusion therapy.
Purpose. This article shows in a schematic and logical manner the mechanism of production in
these reactions, and by this to offer a clear image of the way the treatment works, and prevention
importance.
Materials and Methods. There are sequentially presented: the etiology, pathophysiological
mechanism, clinical signs and symptoms within 24 h, diagnosis and treatment, measures of
prevention, a typical clinical case presentation of the pathology for a much better understanding
of the mechanism and the fast recognition of the pathology.
Conclusion. Taking into account the 2 main types, we can consider that acute reactions are
caused by human errors, frequently in case that group O is given to patients with group A,B or
AB, and also a susceptible category is the patients who receive bone marrow or stem cells that
are incompatible.
The second type, delayed reactions can occur undetected, regularly there are patients that have
had transfusions in the past, or pregnancy, but at the time the titer of the antibodies is too low,
and the reaction was to weak to be detected.
Key words: Hemolytic Reactions, Anti-A antibodies, Anti-B antibodies, Anti-Jk antibodies, Rh
antigen.
86
Po 04. Supraincarcarea circulatorie posttransfuzionala
1
Student, Facultatea de Medicina si Farmacie Oradea, Romania
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea
Introducere. Lucrarea de fata, prezinta unul dintre efectele nefavorabile, relativ comun ale
terapiei transfuzionale si anume supraincarcarea circulatorie.
Scop. In practica medicala exista situatii diverse care pot duce la supraincarcarea circulatorie,
transfuzia in exces fiind una dintre ele, fapt care a motivat interesul nostru pentru acest subiect.
Material si metoda Urmand cursul logic al unei expuneri, am incercat intr-un mod cat mai
schematic si atractiv, sa prezentam aspectele fiziopatologice, clinica, diagnosticul si atitudinea
terapeutica in aceasta situatie, cu sublinierea importantei prevenirii ei. Cazul clinic vine sa
sustina importanta recunoasterii in timp util a supraincarcarii circulatorii (urmarirea si
monitorizarea semnelor vitale) si respectarea criteriilor de administrare a sangelui si produselor
de sange, in context clinic individual.
Concluzii: Scurt si la obiect, proiectul doreste sa atraga interesul unei plaje largi de categorii
profesionale medicale, de la medici la studenti prin paradoxul simplitatii sale ce, in acelasi timp,
nu scapa deloc informatii vitale.
Cuvinte cheie: supraincarcare, terapie transfuzionala, context clinic
87
Po 04. Posttransfusion circulatory overload
1
Student, Faculty of Medicine and Pharmacy, Oradea, Romania
2
High Performance Medical Research Center/ of Medicine and Pharmacy /University of Oradea
Introduction. The presentation is targeted on one of the most common unfavorable effects of
transfusion therapy, known as circulatory over-load.
Aim. In medical practice, there are different situations when circulatory over-load occurs. One of
these, is represented by transfusion in excess, our interest being motivated by this condition.
Material and method Following a logical frame, we tried to express in a very schematic and
attractive manner the patho-physiologic, clinical respects, the diagnosis and therapeutic attitude,
stretching the importance of prevention this medical condition. The case study, supports the
recognition in due time of this pathology (to follow and monitor the vital signs), but mainly the
correct prescription of blood and blood products, according to individual clinic context.
Conclusions. Briefly and pointed, the presentation main purpose is to attract the interest of a
wide range of professional categories, from physicians to medical students; even could be
consider a paradox the simplicity of the topic, it does not lack substance, even vital information.
Key words: Over-load, Transfusion Therapy, Clinic Context
88
Po 05. Insuficienta respiratorie acuta post-transfuzionala
1
Student, Facultatea de Medicina si Farmacie Oradea, Romania
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea
89
Po 05. Transfusion Related Acute Lung Injury (Trali)
1
Student, Faculty of Medicine and Pharmacy, Oradea, Romania
2
High Performance Medical Research Center/ of Medicine and Pharmacy /University of Oradea
90
Po 06. Boala grefon contra gazda post-transfuzionala
1
Student, Facultatea de Medicina si Farmacie Oradea, Romania
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea
Introducere. Deși boala post-transfuzionala grefa-contra-gazda (TA-GVHD) este raportata rar
in ultimii ani, prognosticul extrem de nefavorabil subliniaza importanta cunoasterii tuturor
aspectelor legate de aceasta afectiune.
Scop. Scopul acestei cercetari este descrierea mecanismului care permite dezvoltarea acestei
patologii (TA-GVHD), cunoașterea categoriei pacientilor cu risc, cunoașterea simptomelor si
complicatiilor si de a insista asupra rolului iradierii produsului sanguin in preventia TA-GVHD.
Material si metoda. Mecanismul fizio-patologic/imunologic al aparitiei TA-GVHD are la baza
limfocitele donorului care initiaza un raspuns de rejectie a tesutului gazdei. Simptomele apar
pana la 30 de zile de la transfuzie, facand uneori dificila asocierea simptomelor cu terapia
transfuzionala. Amanarea diagnosticului agraveaza prognosticul care este oricum extrem de
nefavorabil, putand cauza moartea (complicatii ale pancitopeniei) din cauza inexistentei unui
tratament eficient. Cazul clinic selectat si prezentat subliniaza importanta intelegerii patologiei,
recunoasterii preococe, dar mai ales a preventei apartiei..
Concluzie. TA-GVHD in general nu raspunde la tratamentele folosite pentru GVHD in
transplanturile de maduva osoasa, rolul crucial detinandu-l preventia (identificarea pacientilor cu
risc si utilizarea pentru terapie transfuzionala a produselor sanguine (care contin limfocite T
viabile imuno competente) doar iradiate gamma
Cuvinte cheie. reactii posttransfuzionale tardive, iradierea produselor sanguine, imunologic
91
Po 06. Transfusion-Associated Graft Versus Host Disease (TA-GVHD)
1
Student, Faculty of Medicine and Pharmacy Oradea, Romania
2
High Performance Medical Research Center, Faculty of Medicine and Pharmacy, University of
Oradea
Introduction. Although graft-versus-host disease (TA-GVHD) has a relatively low incidence in
recent years, the extremely severe prognosis underlines the importance of being familiar with
specific aspects of presented pathology.
Purpose. The purpose of the presentation is to describe the mechanism that allows transfusion-
associated graft versus host disease (TA-GVHD) to occur, the category of patients at risk, the
symptoms/complications and to insist on the tremendous role of irradiated blood components for
preventing TA-GVHD.
Materials and Methods. The patho-physiologic/immunologic mechanism of TA-GVHD is
represented by donor lymphocytes able to initiate a rejection response of the host tissue. The
symptoms can occur up to 30 days after transfusion therapy, making difficult sometimes to
associate them to prior transfusion. The delayed diagnosis aggravates already extremely
unfavorable prognosis till death (due to complications of pancytopenia) not existing any effective
treatment. The selected clinical case underlines the importance of understanding, early
recognition, but mainly pathology prevention.
Conclusion: TA-GVHD generally fails to respond to treatments used for GVHD following bone
marrow transplants, thus the most effective mean is its prevention by using only irradiated
gamma blood (due to viable, immune competent T lymphocytes presence).
Key words. Delayed Transfusion Reactions, Blood Irradiation, Immunology
92
Po 07. Reactie alergica usoara (urticarie) in relatie cu terapia transfuzionala
Roxana Burta1, Carina Dudas (Petricau)1, Sebastian Stanciu1, Olivia Ligia Burta2,
Stefan Reikli2
1
Student, Facultatea de Medicina si Farmacie Oradea, Romania
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea
Introducere. Reactiile alergice sunt intalnite relativ frecvent, fiind recunoscute ca si complicatii
ale terapiei transfuzionale. Gama de manifestari clinice este redusa: fie eruptii cutanate (urticaria
si angioedemul) fie dispnee, sau o combinatie intre acestea.
Scopul. Prezentarea de fata este motivata de interesul de a arata ca reactiile alergice usoare, pot
apare fie prin mecanism imunologic (cu implicarea IgE sau altor clase de imunoglobuline) sau
non-imunologic. Sunt explicate diferite mecanisme de aparitie, de exemplu: 1. pe de o parte
relationate cu terapia transfuzionala – din cauza prezentei de anticorpi fata de celule sanguine
transfuzate (de ex. anti-HLA, anti-plachete) sau prezenta anumitor proteine (IgA, ale sistemului
Complement) in plasma primitorului, sau in cazul existentei diferentelor alotipice intre donator si
primitor 9de exemplu alotipuri IgE, Complement C4d, haptoglobina) 2. pe de alta parte
independente de transfuzie, de exemplu alergia la latex, sau indusa medicamentos (aspirina).
Material si metoda. Intr-o maniera sugestiva, usor de inteles, prin utilizarea de imagini, scheme
explicative logice, am reusit sa figuram cele mai importante caracteristici etiologice, de
diagnostic, imunologice, ale uneia dintre cele mai comune complicatii induse de terapia
transfuzionala, sustinuti de un caz clinic reprezentativ.
Concluzii. Chiar in conditiile in care personalul medical responsabil de terapia transfuzionala
efectueaza un istoric detailat al pacientului, determina parametrii biologici sanguini (de exemplu
proteine din sistemul Complement) aceasta complicatie poate sa apara; de aceea este foarte
importanta constientizarea personalului asupra riscului de aparitie, impunandu-se monitorizarea
stricta a pacientului in cursul terapiei transfuzionale, iar dezvoltarea alergiilor usoare impun
oprirea transfuziei, cu terapie medicamentoasa corectoare.
Cuvinte cheie. Reactii alergice, dependenta de terapia transfuzionala, intreruperea transfuziei
93
Po 07. Mild Allergic Reaction Transfusion-Related
Roxana Burta1, Carina Dudas (Petricau)1, Sebastian Stanciu1, Olivia Ligia Burta2,
Stefan Reikli2
1
Student, Faculty of Medicine and Pharmacy Oradea, Romania
2
High Performance Medical Research Center, Faculty of Medicine and Pharmacy, University of
Oradea
Introduction. Allergic reactions are not infrequent post-transfusion complication, and may
include local cutaneous reactions (urticaria or agio-oedema) or wheeze, or combination thereof.
Aim. The presentation is motivated by the interest to show that the mild allergic reactions may
be either immunologically based (with IgE or other Igs involvement) or non-immunological.
There are explained different mechanisms of occurence, such as 1. transfusional like: due to the
presence of antibodies to transfused blood cells (eg anti-HLA, anti-platelets) or certain protein
structures (IgA, Complement) in recipient’s plasma or recipient/donor allotypic differences (eg
IgE allotypes, Complement C4d, haptoglobin) and 2. other causes: latex allergy, or drug-
associated (eg aspirin).
Material and method. In an friendly manner, easy to be understood, using pictures, logical
explanatory schemes, we reached our goal to display the most important features regarding:
etiology, diagnosis, immunology of one of the most common post-transfusion complication,
helped by a relevant case report.
Conclusions. Eventhough the medical staff responsible for transfusion therapy do a full clinical
history, with blood testing for Complement proteins) this condition may occur; therefore is
important the clinician to be awared about it, to monitor strictly the patient during transfusion
therapy, and in case of urticaria occurrence, it imposes the discontinuity of the transfusion
therapy, with corrective medication.
Key words. Allergic reactions, Transfusional-like, Transfusion Discontinuity
94
Po 08. Hemoliza acuta post-transfuzionala mediata non-imun
Paula Dejeu1, Adela Vicas1, Danut Dejeu2, Razvan Vicas3, Olivia Ligia Burta4
1
Medic rezident Laborator Clinic, Centrul de Transfuzie Sanguina Oradea, Romania
2
Medic specialist Chirurgie Generala, Spitalul Clinic Judetean de Urgenta, Oradea, Romania
3
Medic rezident Ortopedie, Spitalul Clinic Judetean de Urgenta, Oradea, Romania
4
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea, Centrul de Transfuzie
Sanguina Oradea
95
Po 08. Acute Non-Immune Hemolytic Transfusion Reaction
Paula Dejeu1, Adela Vicas1, Danut Dejeu2, Razvan Vicas3, Olivia Ligia Burta4
1
Clinical Laboratory Resident, Blood Transfusion Center, Oradea, Romania
2
General Surgion, Specialist, Country Clinical Hospital, Oradea, Romania
3
Orthopedic Surgeon Rezident, Country Clinical Hospital, Oradea, Romania
4
High Performance Medical Research Center/ of Medicine and Pharmacy /University of Oradea,
Blood Transfusion Center Oradea, Romania
96
Po 09. Reactiafebrila post-transfuzionala, non-hemolitica
Horatiu Burta1, Teo Rif1, Sebastian Heredea1, Bogdan Leahu1, Catalin Nicolae1,
R. Iovan2
1
Student, Facultatea de Medicina si Farmacie Oradea, Romania
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea
97
Po 09. Non-haemolytic immune transfusion reactions (NHTR)
Horatiu Burta1, Teo Rif1, Sebastian Heredea1, Bogdan Leahu1, Catalin Nicolae1,
R. Iovan2
1
Student, Faculty of Medicine and Pharmacy Oradea, Romania
2
High Performance Medical Research Center, Faculty of Medicine and Pharmacy, University of
Oradea
Aim. The presentation shows the specific conditions of this immune reaction,
underlying the clinical signs (the marker being the temperature rise, with minimum
1 0 C transfusion-related) which can guide to a correct and in due time of therapeutic
attitude.
Material and methods. Using recent bibliographic articles, were selected the most
representative patho-physiologic, immunologic (the most frequent antibodies
involved in this reaction are represented by a nti-leucocytic) clinical (history of
pregnancies, poli-transfused patients) diagnosis schemes, along with the condition
management, and afferent prognosis index.
98
indicated to pacients with history of at least 2 febrile episods transfusion -related in
certain patients categories.
Key words. NHTR, Selected Blood Products, Prevention
1
Medic rezident Laborator Clinic, Centrul de Transfuzie Sanguina Oradea, Romania
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea, Centrul de Transfuzie
Sanguina Oradea
Introducere. Socul septic asociat terapiei transfuzionale, are o incidenta foarte scazuta si este
considerat o complicatie cu potential evolutiv fatal, datorat contaminarii bacteriene a produselor
sanguine administrate.
Scop. Aceasta prezentare are rolul ca intr-o maniera explicita, sa sublinieze importanta
diagnosticarii precoce a acestei patologii cat mai ales preventia ei.
Material si metoda. Descrierea mecanismului fiziopatologic, a semnelor clinice si paraclinice,
diagnosticului si tratamentului specific sepsisului, ajuta la orientarea si intelegerea acestei
patologii. Descrierea unui caz clinic de referinta, orienteaza pe orice practician interesat in
medicina transfuzionala, subliniind totodata importanta asigurarii unui produs sanguin de o
calitate maxima din punct de vedere al securitatii transfuzionale. Pe de alta parte, monitorizarea
atenta pe tot parcursul si dupa terminarea terapiei transfuzionale, asigura un diagnostic corect si
instituirea conduitei terapeutice adecvate in cel mai scurt timp.
Concluzie. Datorita faptului ca la baza aparitiei socului septic posttransfuzional este implicat
produsul sanguin contaminat bacterian, rezida importanta asigurarii calitatii actului
donarii/validarii (microbiologice si macroscopice) a fiecarei unitati de produs sanguin ce
urmeaza a fi utilizat in terapia transfuzionala.
Cuvinte cheie. Soc septic, produs sanguin contaminat bacterian, complicatie posttransfuzionala
99
Po 10. Bacterial Contamination
1
Clinical Laboratory resident, Blood Transfusion Center, Oradea, Romania
2
High Performance Medical Research Center/ of Medicine and Pharmacy /University of Oradea,
Blood Transfusion Center Oradea, Romania
100
Po 11. Trombocitopenia posttransfuzionala (TPT)
1
Medic rezident Laborator Clinic, Centrul de Transfuzie Sanguina Oradea, Romania
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea, Centrul de Transfuzie
Sanguina Oradea
Introducere. Trombocitopenia sau purpura posttransfuzionala este o forma rara dar grava de
trombocitopenie mediata de alloanticorpi, care apare in urma transfuziilor de sange sau masa
trombocitara.
Scop. Acest studiu a urmarit depistarea si intelegerea proceselor fiziopatologice si imunologice,
precum si efectele clinice ale trombocitopeniei posttransfuzionale, in vederea identificarii unor
metode de preventie sau a depistarii precoce a acestei patologii.
Material si metoda. Intr-o maniera schematica dar sugestiva este descris mecanismul
fiziopatologic, semnele clinice si datele paraclinice, diagnosticul si tratamentul specific al TPT.
Prezentarea unui caz clinic de referinta, sustine intelegerea si recunoasterea cu usurinta a acestei
patologii, de catre personalul medical implicat in actul trasfuzional si nu numai.
Concluzie. Datorita faptului ca in mecanismul fiziopatologic de producere al trombocitopeniei
posttransfuzionale sunt implicate antigenele HPA-1a, administrate odata cu transfuzia de sange
sau masa trombocitara la un pacient HPA-1a negativ, este esentiala identificarea acestor pacienti
si preventia TPT prin transfuzii de sange HPA-1a negativ. Pe de alta parte, daca un pacient
prezinta trombocitopenie in urma unei transfuzii trebuie considerata posibilitatea unei dezvoltarii
TPT, targetul fiind un diagnostic corect si instituirea conduitei terapeutice adecvate.
Cuvinte cheie. Antigen HPA-1a, alloanticorpi, complexe imune, hemoragie.
101
Po 11. Posttransfusion Purpura (PTP)
1
Clinical Laboratory Resident, Blood Transfusion Center Oradea, Romania
2
High Performance Medical Research Center/ of Medicine and Pharmacy /University of Oradea,
Blood Transfusion Center Oradea, Romania
102
Po 12. Reactie alergica severa-soc anafilactic
1
Student, Facultatea de Medicina si Farmacie Oradea, Romania
2
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea
3
Centrul de Transfuzie Sanguina Oradea, Romania
Introducere. Desi reactia anafilactica datorata administrarii produselor din sange are incidenta
scazuta, severitatea clinica motiveaza interesul prezentarii ei.
Scop. Scopul acestei lucrari este de a explica mecanismul imunologic al ATR (Anaphylactic
Transfusion Reaction), etiologia sa si de a intelege importanta prevenirii aparitiei, folosind fie
produse din sange “deficiente in IgA”, fie hematii sau trombocite ``ultra-spalate`` ori de cate ori
se impune.
Material si Metoda. Debutul rapid al reactiei anafilaxice, manifestat prin soc, hipotensiune,
angioedem si disfunctie respiratorie, necesita recunoasterea cat mai precoce, cu atitudine
terapeutica rapida si eficienta. O reactie anafilactica posttransfuzionala poate aparea de la cateva
secunde pana la cateva minute dupa administrarea unei varietati de produse sanguine, cum sunt:
plasma proaspata congelata, concentrat eritrocitar, trombocite standard sau concentrat,
granulocite, crioprecipitat sau gamaglobuline. Cazul clinic prezentat, sta la baza intelegerii
mecanismul fiziopatologic, insistand asupra tratamentului, dar mai ales asupra preventiei
aparitiei reactiei.
Concluzie. Reactiile transfuzionale se datoreaza adesea “erorilor inocente``, cu o plaja larga de
manifestare clinica, de la simple la urgente “amenintatoare de viata”. Recunoasterea precoce,
intreruperea tratamentului si instituirea terapiei de suport, stau la baza amendarii reactiei.
Raportarea reactiilor postransfuzionale ajuta la imbunatatirea practicii transfuzionale si la
reducerea eventualelor evenimente nedorite.
Cuvinte cheie. Anafilaxie, produse sanguine, practica transfuzionala
103
Po 12. Posttransfuzional Severe Allergic Reaction- Anaphylactic Shock
1
Student, Faculty of Medicine and Pharmacy, Oradea, Romania
2
High Performance Medical Research Center/ of Medicine and Pharmacy /University of Oradea
3
Blood Transfusion Center Oradea, Romania
Introduction. Although anaphylactic reaction to blood products is rare, its severity motivates
our interest in presenting the main respects.
Purpose. The purpose of the presentation is to point the immunological mechanism of
Anaphylactic Transfusion Reaction (ATR), its etiology and the importance of prevention (using
either IgA-deficient blood products or "ultra-washed" red cell or platelet products) is necessary.
Materials and Methods. Rapid onset of anaphylaxis, manifested by shock, hypotension,
angioedema, and respiratory distress, in a transfusion recipient requires early recognition and
concomitant specific action since it is a life-threatening condition. An anaphylactic transfusion
reaction (ATR) may occur within a few seconds to a few minutes following the initiation of a
transfusion that contains frozen plasma, red cells concentrate, standard or concentrated platelets,
granulocytes, cryoprecipitate, or gamma globulin. Based on the clinical case and on the patho-
physiological mechanism with all the clinical manifestations it can be point out that practitioners
have to be aware of prevention and rapid treatment of this acute reaction.
Conclusion: Transfusion reactions are mostly due to clerical errors and can range from benign
reactions to life threatening emergencies. Early detection, discontinuation of transfusion and
instituting supportive care are keys of management. Reporting of all reactions helps to improve
transfusion practices and reduce future potential occurrences.
Key word. Anaphylaxis, Blood Products, Transfusion Practice
104
po 13. Coagulopatia intravasculara diseminata (CID) post transfuzionala
1
Student, Facultatea de Medicina si Farmacie Oradea, Romania
2
Medic rezident Hematologie, Centrul de Transfuzie Sanguina Oradea, Romania
3
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/Uoradea
Scop. Scopul lucrarii este de prezenta si indica semenele si simptomele reactiilor transfuzionale,
necesitatea unei recunoasteri imediate si a investigatiilor de laborator si control clinic.
Concluzii. Deoarece reactiile trasfuzionale hemolitice sunt printre cauzele CID, fiind rezultatul
reactiei anticorpilor din plasma primitorului directionati impotriva eritrocitelor donorului, se
impune respectarea stricta a calitatii actului transfuzional.
105
po 13. Transfusion-Related Disseminated Intravascular Coagulation
1
Student, Faculty of Medicine and Pharmacy, Oradea, Romania
2
Resident of Hematology, Blood Transfusion Center Oradea, Romania
3
High Performance Medical Research Center/ of Medicine and Pharmacy /University of Oradea
Aim. The study’s aim is to present and show signs and symptoms of transfusion reactions, the
need for immediate recognition and for laboratory investigations, along with clinical
surveillance.
Materials and methods. The importance of identifying clinical signs of hemolytic transfusion
reactions, such as disseminated intravascular coagulation, is given by the violent reactions of
incompatibility of blood donor antibodies with those of recipient, leading to death, if there is no
prompt intervention, before the blood unit is completely transfused. The study will be ruled
through description and schematic presentation of the pathophysiological mechanism, clinical
and paraclinical (immunologic) diagnosis, along with a case study.
Conclusions. Because transfusion hemolytic reactions are among the causes DIC, being the
result of antibodies in recipient’s plasma directed against the donor’s erythrocytes, the
transfusion act requires the standards of quality to be strictly respected.
106
Po 14. Contaminarea microbiana; agenti infectiosi cu potential de
transmitere transfuzionala
1
Centrul de Cercetari in Medicina de Inalta Performanta/FMF/UOradea
2
Centrul de Transfuzie Sanguina Oradea, Romania
3
Student Facultatea de Medicina si Farmacie/UOradea
Material si metode. Schemele si diagramele vor incerca sa puncteze intr-o maniera care tine
cont de incidenta/prevalenta varietatii microbiene, de aspectele epidemiologice, cat si infectioase
ale fiecarui agent in parte. Se vor prezenta de asemenea protocoalele specifice stabilirii statusului
de contaminare microbiana, insistandu-se asupra acelora care implicavalidarea microbiologica a
sangelui si produselor sanguine.
107
Po 14. Microbial Contamination, Infectious Agents with Potential
Transfusion Transmission
1
High Performance Medical Research Center /FMF/UOradea
2
Blood Transfusion Establishment Oradea, Romania
3
Student Faculty of Medicine and Pharmacy/UOradea
Aim. Will be presented the microbial etiology (bacteria, viruses, parasites) from etiology, to
microbial characteristics, clinics, diagnosis of those with potential transfusion transmission.
Material and methods. The selected schemes and diagrams try to underline the manner of being
infectious of the large variety of microbs, according to their incidence, prevalence, and clinics as
well. Will be presented the specific protocols in establishing the status of bacterial
contamination, insisting on those involved in microbiologic validation of blood and blood
praducts.
Conclusion. Is important to be known, awared and visualized the most frequent etiologies, in
order to understand the transmission route, and mainly the prevention measures, as major
criterion of transfusion therapy quality.
108
Index autori /Index of Authors
Marie-Emmanuelle Behr-Gross, 10
A
Max Constantinescu, 22, 23
Alietta Florian1, 20, 21 Mir Hajra,80, 81, 82, 83
Andrei Rosin, 18, 19, 74, 75 Mir, Hira1, 80, 81
Andrei Tarsoly, 86, 87
O
B
Olivia Ligia Burta, 10, 14, 71, 77, 80, 81, 84, 85, 86
Bogdan Leahu, 107 Olivia Ligia Burta, 24, 25, 84, 85, 86, 87, 88, 89, 90, 91, 92,
93, 98, 100, 101
C Ovidiu Burta,3, 69, 81, 82, 83
G S
Gilles Follea, 10,28,74 Sebastian Stanciu,92, 93, 96, 97
Sevastiana Bran, 56
I Simona Parvu, 44, 45, 46, 48
Snezhana Chichevaliev, 10
Ioana Zaha, 84, 85 Stefan Reikli, 92
J V
Jean Gerota, 66 Valentina Hafner, 10
1
Victoria Halmagi , 58, 62
L
Lavinia Florentina Rad, 90, 91
W
Leila Curtamet, 22, 23 Wr Mayr, 28, 29
M Z
Mariana Maier, 16 Zoia Bitea2, 20, 21
109