Haemovigilance Recipients at the Rabat Regional Blood Transfusion Center 2015-2019

I Lemssahli¹*, K Hajjout¹, M Benajiba² and A Belmekki³

¹Rabat Regional Blood Transfusion Center, Morocco
²National Center for Blood Transfusion and Hematology, Morocco
³Blood Transfusion Service at the Military Hospital, Morocco

*Corresponding Author: I Lemssahli, Rabat Regional Blood Transfusion Center, Morocco.

Received: December 18, 2020; Published: February 22, 2021

Citation: I Lemssahli., et al. “Haemovigilance Recipients at the Rabat Regional Blood Transfusion Center 2015-2019”. Acta Scientific Paediatrics 4.3 (2021): 56-63.

Abstract

Introduction: Haemovigilance is an element of transfusion safety. Its operating indicators are based on the traceability of transfused bags and the reporting of transfusion incidents.

The objective of this study is to analyze the haemovigilance records returned to the Rabat Regional Blood transfusion center and all RAR notified over a 5-year period, in order to assess the rate of traceability and the incidence of adverse effects of transfusion therapy in healthcare services.

Material and Methods: January 1, 2015 to December 31, 2019, we counted 68,106 files returned to the haemovigilance service of the Regional Blood Transfusion Center that were analyzed, for a total of 84,722 LBP traced including 181 declared incidents.

Results: Feedback from delivered LBPs is very low; the traceability rate for LBPs is 20%. Transfusion incidents declaration average rate is 0.41/1000LBPs.

Non-hemolytic febrile reactions and allergic reactions accounted 76% of the reported RARs. Grade 1 accounted 85.34% of RARs. The "serious" reactions (severity grade> 1) represent 10%. These reactions include one case of volume overload, 03 cases of pulmonary edema of which one was fatal, 06 cases of ABO incompatibility of which two were fatal, 03 cases of convulsions, and 05 states of shock of which 02cases required intensive care.

The RARs were secondary to the transfusion of red blood cell concentrates in 70%.

Conclusion: The rate of feedback and the number of RARs declared by the healthcare services remain underestimated. The involvement of healthcare establishments in the haemovigilance process is a legal obligation in Morocco since 2005, remains poorly respected to this day. Awareness and motivation of nursing staff, improvement of the RARs reporting system and redynamization of transfusion safety and haemovigilance committees (CSTH) guarantee better transfusion safety.

Keywords: Haemovigilance; Feedback; Recipient Adverse Reactions; Labile Blood Products; Blood Transfusion Safety; Moroccan Legislation

Introduction

  Haemovigilance, term resulting from the fusion of the Greek word "haema" means blood and the Latin word "vigil" means vigilant. The concept of haemovigilance appeared for the first time in France in 1990, almost with the same ideas and the same vision of pharmacovigilance [1].

  Haemovigilance is define as the set of monitoring procedures organized from the collection of blood and its components to the monitoring of recipients, with a view to collecting and evaluating information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products and prevent their appearance [2].

  Nowadays, haemovigilance systems have been applied in most developed countries, to monitor adverse events and episodes related to donated blood and transfusions. It is recognize as an integral part of the quality management system of a blood transfusion program [3].

  In Morocco, haemovigilance began in 1993 at the Ibn Rochd university hospital in Casablanca; the notification of transfusion incidents did not become a legal obligation until December 05, 2005 [4] with the publication of the text of the law in Official Bulletin n° 5375.

  The functioning of haemovigilance is measured through the traceability of LBPs delivered to healthcare establishments (HE) and the declaration of recipient adverse reactions (RARs). This operation requires close collaboration between blood transfusion center (BTC) and healthcare establishments (HE) for the exchange of information between the two establishments.

Haemovigilance can only be conceives if the prerequisite for the traceability of labile blood products, from the donor to the actual recipient, is obtained [5].

  The objective of our work is to assess the traceability of labile blood products (LBPs) distributed to the various (HE), to identify and analyze the adverse reactions of recipients declared from January 01, 2015 to December 31, 2019 and compare them with those found in other countries with more experience in this field.

Materials and Methods

  Every year, the Rabat Blood Transfusion Center (BTC) delivers more than 80,000 LBPs to ensure transfusion therapy in more than 60 healthcare establishments (HE), distributed among university hospital center (UHC), public hospitals, private clinics, blood banks.

  The data that we have used come from the haemovigilance records returned to the BTC after used the LBPs. These computerized forms accompany the delivery note (DN) for each labile blood product (LBP).

  The information collected on these forms includes the number of the delivery note; the bar code of the product (BC), the BC of the donation; the identity of the patient (last name, first name), confirmation of the use of the LBP and the signature of the physician in charge.

  In the case of recipient adverse reactions (RARs), transfusion incident sheets are complete by the haemovigilance correspondent of the HE or by the doctor responsible for the transfusion procedure.

  This information concerns the patient (name, first name, age and sex), the incident (clinical manifestations, severity, date and time of onset of the RAR), the LBPs (type, number of donation, the quantity transfused) the healthcare establishment and the signature of the doctor in charge.

  The HE is required to return the transfusion incident sheets, the implicated bag and a post-transfusion sample from the patient to the transfusion center for the control of the immuno-haematological examinations.

If a bacterial infection is suspect, the product will be analyze at the bacteriology laboratory of the Rabat University Hospital Center.

Results

From January 01, 2015 to December 31, 2019, the Rabat BTC delivered 432,868 PSL to different care establishments, 61% of LBPs delivered are CGR, 22% PLQ and 17% PFC.

  Histogram1 shows that the annual number of LBPs delivered is around 83,000 PSL between 2015 and 2017. In 2018 and 2019, there was an increase of 10% of products delivered concerning RBCs and PLQs, Mainly due to the opening of new hemato-oncology clinics.

Histogram 1: Delivery of LBPs 2015-2019.

Over the five years, 84,722 LBPs of the total 432,868 LBPs delivered have been traced.

  The comparative analysis of the traceability of the number of labile blood products according to years shows a reduction in traceability in 2016 followed by a maximum traceability in 2017, then a decrease in 2018 to stabilize until 2019 (Table 1).

The average traceability rate calculated is 20%. (Table 1) of the public HE 12% and 8% of the private HE, while untraced LBPs represent the vast majority 80%.

Year	Number of PSL delivered Public HE	Number of PSL delivered Private HE	Number of LBPs traced Public/Private	%Return information RI	Number of RARs	Incidence RARs /1000 LBPs
2015 2016 2017 2018 2019	57072 58701 58795 63142 62227	26119 24128 24745 28089 29850	16292 12414 22746 16650 16616	19,58% 15% 27,22% 18,25% 18,04%	36 40 42 32 31	0,43/1000 0,48/1000 0,50/1000 0,38/1000 0,34/1000
Total	Total LBPs delivered432868		Total LBPs traced 84722	Average traceability rate 19.55%.	181	0,43/1000LBPs

Table 1: Feedback of LBPs delivery2015-2019.

As for recipient adverse reactions (RARs), 181were declared. Analysis of the number declared annually shows great instability (Curve 1).

Curve 1: Evolution of the declaration of RAR.

  Between 2015 and 2017, the period marked by an increase in declarations from 36 to 40 to reach 42 RARs declared in 2017. Between 2018 and 2019, there was a significant decrease declaration not exceeding 32 RARs. The overall cumulative incidence of RARs is 0.41 RARs/1000 LBPs delivered.

The average age of the patients is 44.3 years with extremes (03 months to 65 years), 56.7% are female; 60% of the reports came from the hemato-oncology and pediatrics departments.

  The majority of the reported reactions were febrile non-hemolytic reactions (40.5%) and allergic reactions (35.5%), followed by reactions such as chest manifestations (dyspnea, chest pain, etc.). (8.15%), digestive manifestations (Abdominal pain, nausea, vomiting. (9.5%) (Histogram 2).

Histogram 2: Distribution RARs.

  All the reported reactions were immediate events, with 85.34% of grade 1 (histogram 3), grade 2 and 3 representing 7.45% and 4.96% respectively, divided between transfusion-associated volume overload (0.55%), pulmonary edema (1.10%), possible TRALI (0.55%), convulsions (1.65%), Shock (2.76%), ABO incompatibility (3.31%).

As for Grade 4 (1.65%), we identified three (03) post-transfusion deaths that occurred in 2017, two deaths due to ABO incompatibility and the 3rd case due to TRALI (Table 2).

Histogram 3: Severity grade of RARs.

  The haemovigilance survey around the various adverse effects shows that red blood cell concentrates are significantly more involved in these RARs (70%), followed by platelets in 27% and in third place PFC3%.

Characteristics	1st case	2nd case	3rd case
Cause	Incompatibility ABO	Incompatibility ABO	TRALI
Incriminated LBPs	RBCs	RBCs	FFP/Platelets
Imputability	Certain	Certain	Possible
Hemovigilance investigation	Sampling error Ultimate check not done	Sampling error Ultimate control uninterpretable	Rx in favour of pulmonary edema

Table 2: Grade 4 Gravity of RARs.

Discussion

  Haemovigilance is an information system on transfusion and part of the transfusion security system [5]. It may only be conceived if the pre-requisite for the traceability of labile blood products from donor to the recipient is obtained [6]. Effective haemovigilance requires close collaboration between the different actors of BTC and HE.

This collaboration remains very unsatisfactory, reflected by the average traceability rate recorded in our study, which does not exceed 20%.

  S.Oudghiri., et al. reported a traceability rate of 15.5% [7] raised the same observation in 2012. Compared to international data, these values are very low. In fact, French haemovigilance reports a traceability rate of 98.9% [9].

In other European countries and North America, the traceability rate reaches 100% [5,10].

The analysis of the evolution of the traceability rates in our series shows that the rates are very low and irregular.

  In 2017, the rate of traceability has reached its maximum value (27.22%), due to the impact of the training, information and awareness-raising sessions that the Rabat BTC has provided to the HE and to the permanent follow-up of feedback. This action is difficult to maintain all over the year because the BTC correspondent is generally in charge of other responsibilities or activities.

  As part of a University research carried out at the Rabat pediatric hospital on the factors hindering product traceability, it shown that 80% of the hospital's nursing staff say they are demotivated by a lack of awareness, continuous training and lack of computerized support for traceability.

  S. oudghiri., et al. have raised that healthcare staff lack involvement and consider traceability to be a workload, an administrative constraint more than a tool for improving transfusion quality [7].

The above-mentioned dysfunctions reflect the organizational, functional and legal deficiencies of the Moroccan haemovigilance system.

  The successful development of any haemovigilance system is inconceivable without the implementation of a good communication system between the different actors and the motivation of the care staff [7,11].

  The reporting of RARs is part of transfusion safety. It identifies the risks associated with LBPs transfusion and allows corrective measures to be adopted to control and prevent them [1,5].

In our series, 181 RARs notified, the analysis of the annual cumulative incidence of RARs from 2015 to 2019 (Table 1) shows that the rate does not exceed 0.41/1000 PSL.

Compared to the international data, these values are very low [8,9].

The low rate can only be explained by underreporting and not by a real decrease in transfusion reactions probably due to the underestimation of minor accidents.

  The analysis of the evolution of the annual cumulative incidence of RARs (Table 2) shows that the declaration rate reached its maximum 0.50/1000 LBP in 2017, this peak is explained by the involvement of new healthcare establishments as well as the multiplication of training sessions during this year.

  In the present study, the primary cause of transfusion reactions was febrile non-hemolytic reactions (FNHR) (40.5%). This accident is secondary to alloimmunization against leukocyte antigens [13]. This pathology must remain a diagnosis of exclusion and not be confused with the initial phase of septic shock or ABO incompatibility [12].

The second highest frequency concerns allergic reactions (35.5%).

Both of these two reactions account for 76% of all RARs. This finding is compatible with the national and international data [8,5-11].

  FNHRs were all immediate reactions, clinically manifested as chills-hyperthermia syndrome occurring during transfusion. All the patients in our series presented a sudden thermal rise of 1°C not exceeding 38°C from the initial temperature before transfusion, often associated with minor subjective signs such as a feeling of cold, discomfort, malaise, difficulty breathing, headache, nausea and vomiting, tachycardia or low blood pressure, resulting in cessation of transfusion in the majority of BPL recipients. All the signs have disappeared spontaneously or under symptomatic treatment a few hours after stopping the transfusion.

  In France, their incidence is estimated by the ANSM at 1 per 1632 LBPs transfused per year. It is the second complication of blood transfusion [12,13]. The requirement for leukodepletion significantly reduced these events.

  The FNHRs are observed especially after transfusion of platelet concentrates to immunize patients. The transfusion of platelets with a short shelf life and deplasmatization are the most suitable solutions for the prevention of iterative RFNH [12,13].

In Morocco, leukodepletion of the concentrated red blood cells is not yet systematically applied and is doneat the request of the clinician.

The training sessions on the importance of leukocyte depletion of LBPs have contributed significantly to the drop in NHFTRs compared to the rates published in 2016 [8].

  The policy of the National Blood Transfusion and Hematology Center (CNTSH) provides in its 2020-2025 action plan for the systematic leukodepletion of red blood cell concentrates and the development of inactivation of germs [15].

  The second highest frequency was for allergic reactions (35.5%). They appear during or after the transfusion. They often occur early and abruptly after the start of the transfusion. The path physiology of allergic transfusion reactions remains poorly understood, often involving several factors that may be interrelated and may originate from the recipient, the donor and the LBPs [16].

  In France, it is estimated the incidence of RAR is one reaction per 3,229 LBPs transfusions per year [12,17]. The risk of transfusion allergy is highest in the age group from 1 to 19 years [17]. Platelets mainly cause this complication, with an estimated incidence of 1 event per 200 platelet concentrates transfused [12,17]. Different clinical manifestations of various severities are reported [12] but most of the reports are grade 1 [18].

American and British studies have implicated the potential role of plasma in inducing these manifestations [5].

  The deplasmatization of red blood cells, the introduction of a platelet storage solution, leukodepletion and the reduction of the stocking time of BPL appear to be factors that reduce the frequency of allergic reactions [12,14].

  In our series, 63 cases of reported allergic reactions are immediate grade 1. These allergic reactions occurred most often during transfusion of platelets: 26 cases (41.2%); 20 cases (31.7%) following transfusion of RBCs and in 17 cases (26.90%) FFP was the cause.

The pediatric haematology-oncology services were the services that reported more than 60% of these reactions. Our results are in line with those of the literature.

  Out of 181 notified RARs, 10% were "serious" (severity grade> 1). We give particular importance to two types of incidents, the first poorly known TRALI and the second poorly managed incident: ABO incompatibility.

  TRALI: acronym for “transfusion related acute lung injury”, was defined in 2004 by the Toronto consensus conference [12,19] as lesional pulmonary edema occurring within 6 hours after the end of a transfusion and progressing to acute respiratory distress syndrome ̈ (ARDS) without any other factor of ARDS [12,19]. RX pulmonary will reveal bilateral infiltrations corresponding to pulmonary edema [19-22]. To date, the diagnosis of TRALI remains as defined in the Canadian consensus criteria and the eventual TRALI (p-TRALI) is still used in cases where a patient develops mild ARDS associated with a transfusion [20,21].

TRALI has an estimated incidence of almost 1/5,000 labile blood products [20]. It is now the leading cause of post-transfusion death in the United States [20].

In French haemovigilance, its incidence is estimated at 1/55,289 LBPs, representing the 3rd cause of death [12].

  Most cases of TRALI (80-85%) have been associated with the presence of anti-human lymphocyte antibodies (HLA) or anti human neutrophils (HNA). All blood products have been implicated in the development of TRALI, although products rich in plasma have historically been most commonly implicated [12,21].

The diagnosis of TRALI is based solely on its clinical presentation and depends on a high level of suspicion and bedside vigilance, as it is a commonly underreported entity [22].

In our study, we report three cases of post-transfusion pulmonary edema that may fall within this framework with an incidence of 0.007/1000 PSL transfused.

  The diagnosis of possible TRALI (p-TRALI) is retained in 02 patients aged 35-58 years respectively, occurred following the transfusion of FFP, the patients presented clinical signs such as fever, dyspnea, tachypnea, pulmonary crackles and hypotension with no radiological signs. The progression was favorable in a few hours with simple oxygen therapy.

  The TRALI was diagnosed in a 55-year-old patient who presented, in addition to the above clinical signs, radiological signs like bilateral pulmonary infiltrations. This incident was the result of a transfusion of FFP and platelets. The outcome was adverse and death was reported in the hour following the transfusion (Table 2). The incidence described in our study is far from that in the ANSM Haemovigilance Report [18]; the reason for this can only be explained by underreporting by the clinicians, the possible cause of their lack of knowledge.

  The second serious incident is ABO incompatibilities that require particular attention, as they are entirely preventable by compliance with good transfusion practices and procedures; they are potentially a source of significant morbidity and mortality. They result from an incorrect administration of LBPs, which is the consequence of a mistake or a series of mistakes along the transfusion chain: error of attribution, incorrect identification of the patient/LBPs.

  Data in the literature show that in over two thirds of cases, the main source of dysfunction is the failure of the hospital to provide pre-transfusion control at the patient's bedside, which is the last safety lock [23].

  Over the study period, six cases of ABO incompatibility were declared, with an incidence of 0.014/1,000 LBPs (05 were children between 1 and 12 years and 01 were female 79 years old). 2.20% are in grade 2 and 1.10% in grade 4 (Table 2).

  In our series, the incidence of ABO incompatibility is higher than that reported by the Casablanca and Rabat team [5,8] and is similar to the published incidence in the Maghreb [24,25].

All cases clinically presented a hyperthermia, changes in Systolic Blood Pressure, back pain, haemoglobinuria in 4 cases and fatal shock in 2 cases.

  Our Haemovigilance investigation of the 06 cases of ABO incompatibility found that the incompatible transfusions resulted both from human error and failure to comply with good transfusion practices as described in the literature [12,23].

Continuous awareness raising and training of medical and paramedical staff is a key element of transfusion safety in ensuring good feedback and better notification of RARs.

Conclusion

  Haemovigilance is a process of quality to improve and increase transfusion safety. It is covering and monitoring all the activities of the transfusion system. The Moroccan Haemovigilance system is inspired by the French system in its concepts and structures.

  Unfortunately, we note important deficiencies in the development of the national haemovigilance system expressed by: A very low rate of feedback from the LBPs and an under-reporting of transfusion incidents; due to non-compliance of the texts of legislation published in 2005 and 2007anda low involvement of HEs in the process.

It is imperative in view of the slow implementation of the system and non-compliance with the regulations in force:

• Establish a development strategy to deal with the difficulty of setting up the system.
• Review the national organization of the haemovigilance system.
• Revitalize the transfusion security and haemovigilance Committee that guarantees transfusion safety.
• Create an independent national instance that monitors the application of good transfusion practices in the HE in order to make the laws published in 2005 operational, this instance must be able to motivate and reinforce the staff.
• Implement corrective actions oriented towards training and regular awareness raising of healthcare personnel.
• Develop and dynamite communication between the different stakeholders.
• Develop the support for the declaration of RARs, and set up a software program via a network between BTC and HE to improve the reporting of RARs, secure data
• collection and facilitate the work of reporters and haemovigilance correspondents.

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