INTRODUCTION:

According to WHO, a regulation was framed to Blood transfusion safety by introducing a term called Haemo-vigilance which is about continuous monitoring of blood for possible risks. This is completely about a surveillance procedure, which starts from the collection of blood and components, analyzing, processing, storage and till it reaches the receivers.

The blood transfusion process is a Risk related operations which can easily affect the quality of blood and its components by contamination of external factors and errors. In recent years there was a many controversies and issues were involved in Blood transfusion, like incorrect and infected blood was transfused to the patient, which has caused many harmful effects to the patients by occurring of life-threatening diseases and sometimes death.

In developed countries, a successful Haemovigilance was implemented by developing and collaborating with a standard network on International Haemovigilance Network (IHN) and International Society on Blood transfusion (ISBT), which was a major working committee. In the case of emerging countries still, there is an improvement needed for Blood transfusion safety by implementing Haemovigilance from the base by following the international standards and building networks. There are also some challenges involved in setting up HV which will vary on country's regulations and also population basis. Analyzing the current trends and adequate requirements were needed for bringing a successful outcome.¹

BACKGROUND:

· To learn Haemo-vigilance role around the world

· To learn about the Risks and Safety measures to handle with Blood transfusion process.

· To learn what are the strategies to be followed for Implementing Haemovigilance in emerging countries seeking for blood transfusion safety regulations

· To set Standard on quality for collecting a sample, analyzing, storing process and distribution of Blood and its components

· To set requirements for traceability and notifications on serious effects

· To obtain information on Case studies based reports

· Evaluation of Risks and analyzing the root causes

· Giving key recommendations in a case for preventing further adverse issues and barriers.

Methods include the following:

· Providing brief introductions and Overview about Haemovigilance According to WHO

· Finding the Root causes of errors occurred in Blood transfusion

· Implementing the Haemovigilance based on obtained case study reports conducted by the health professions and medical staff.

· Providing Recommendations/Solutions by knowing Root causes

· By considering Regulatory Requirements and its importance to avoid risk factors/Adverse events in the future.

DISCUSSION:

Reasons Why Haemo-vigilance:

· Errors in the collection of blood samples while testing

· Significant deviations from the protocols

· Incorrect blood products transfused

· Adverse reactions and inappropriate use of blood

· Lack of confidence produced from recipients²

Adverse reactions of Blood transfusion:

The major reason for death during or after the blood transfusion process is a condition of occurring known as Acute hemolytic transfusion reactions (AHTRs).³

Related errors:

· Delayed hemolytic/ Serologic transfusion reactions

· Hypotensive transfusion reactions (HTR)

· Post-transfusion purpura (PTP)

· Transfusion-associated circulatory overload (TACO)

· Transfusion-related acute lung injury (TRALI)

Why are there so many mistakes in blood transfusions?

"Every blood bank should have an advisor. The background of the rhythmic suppliers should know the details of his health and get the bloodstream. The doctors in the blood bank will decide whether or not to use blood tested or not. But social activists blame that this practice will not be followed in many places.

Every man's body has an average of four to five and a half liters of blood. The blood is collected only from 350 m to 450m. Then, red blood cells, blood tissues, and plasma are extracted and preserved at suitable temperatures for a while. Accordingly, pureblood (35 days), blood red blood cells (42 days), blood tissues (5 days) and plasma (1 year) are preserved. Do not use them after this period.

There are several phase tests before blood transfusions. First, the test will be tested for the patient. Even if 1% of the rules are implemented, there is no way to make mistakes. In 2002, the Government developed the National Blood Transfusion Policy to eliminate the problems in the blood supply and the blood transfusion of patients. Accordingly, the law for setting up blood banks was formalized. A blood bank requires at least 1,100 square foot space to start. A doctor who has been trained in the blood bank must be on duty. The worker must have a one-year experience. A nurse will also have a job. But there are no regularly trained doctors in many of the blood banks currently operating.

The registration room, reception area, donation area, counseling room, and leisure room should be required for the blood bank. There should be two labels apart. In the first label, you need to find the bloodstream and the second lapse in the blood. Apart from this, there is room for cleaning (sterilize) and record rooms. Donors, blood details and experimental details should be kept in a record format for 5 years. The fridge is mandatory. The ordinary bank has a room with 4 ACs. If there are tools to divide the blood vessels, we have a room with 6 ACs.

There are modern amenities with refrigerators for maintaining blood. The temperature ranges from 2 degrees to 6 degrees. The temperature is recorded every minute. Hence, it can be monitored daily and can determine if the blood is safe. If the power is disconnected, the blood will be spoiled. UPS and Generator facility is also essential. The temperature will be monitored every 4 hours with the help of a thermometer. Besides, there will be a digital recorder and alarm facilities. Every month, check 4 blood packets and make sure the blood is not spoiled. There are mistakes when these rules are not detected.³

Challenges involved in implementing Haemovigilance:

· Challenges will vary based on Country-specific guidelines

· A mutual understanding between Health officers/Authorities

· Acceptance from the Working Committee members

· The difference in the population and characteristics

· Lack of giving importance to Blood transfusion safety.

A Database ISTARE captures the following data:

· Representing schematic work and principles of the Transfusion chain.

· Provides statistical data of blood grouping based on donor classification

· Specific blood types of components which was issued and transfused

· Incorrect amount of blood component that was transfused.

The online-based database process enables annual data collection for analysis from any country which gathers Haemo-vigilance data and permitting it for comparisons and assessment depends on trends.⁴

Strategies for the Implementation of Haemovigilance:

To determine the current issues and controversies associated with the Blood transfusion safety and to obtain the reports from the case studies where the patients affected severely due to the Blood transfusion errors in various basis and providing the right solutions and recommendations in order to develop the emerging field of Haemovigilance and to insist their importance to the public as well as health authorities and working committee members who are responsible for the organization of Blood transfusion process.⁵

Table.1 - Root Cause Analysis: ⁶

FACTORS	TYPES
Patient Factors	Clinical conditions, Physical and Psychological factors
Individual Staff Factors	Physical issues and cognitive factors
Communication Factors	Verbal, Written, and Management
Working Condition Factors	Administrative, Environment, Workload and Time factors
Team Factors	Leadership, Support, and Cultural factors
Task Factors	Guidelines, Protocols, and Task designs
Equipment Resource Factors	Integrity, Displays, and Usability

Key Recommendations:

Based on the detailed study of various aspects of Blood safety issues/Regulatory Guidelines and expectations, Learnings from various regulatory aspects the following are recommendations to prevent and proactively avoid Blood safety issues to safeguard the Blood transfusion process and reputation for long-lasting sustainable confidence among people.

· There should be a well-trained person who is involved in this process

· Focus on building Quality culture

· Facilitate the education system for the people about the safeness of the transfusion process and also provide education on their ethics involved.

· Focus on advanced systems and procedures involved in blood transfusion safety and related aspects.

· Ensure quality and safety in the blood transfusion process.

· Focus on case studies and risk-related problems to avoid further risk-related issues.

· Involve conferences and meetings conducted by IHN and ISBT conferences which are framed By WHO.

· Focus on better Process understanding than traditional Trial and error approach

· Generate data standards are recommended

· Improved reporting capacity is also recommended.

· In case of monitoring advisory program, updates were still expected to come concerning:

· Safety of blood and its component

· Patients satisfaction

· Focus on developing Cross-functional teams for improvements/Incident investigations/ Troubleshooting and form Quality circles.

· Focus on effective training and evaluate; explore to measure the benefit of Training.

· Provide required, adequate management support in terms of resources.

· Understanding the current scenario of Blood availability in case of transfusion process.

· Focusing on key elements involved in the haemovigilance program for core processing.⁷

RESULTS:

From the above observations and evaluations are resulted as:

Basic definitions and understanding of Haemovigilance and their importance for the betterment of the Blood transfusion system to improve safety. Determined the committees and authority members involved in National and International aspects of this system and their roles and responsibility were carried out throughout the system. Evolution of regulatory requirements and guidelines issued for building a safety culture on possible risks and adverse events by avoiding the errors occurred usually. Training staff members who are involved in the study should be given without any failure and negotiation.

There were many Non-Compliance issues with the Guidelines which are framed by the regulatory agencies, usually deviates from the protocols during the study or process of Blood transfusion. There was a lack of compliance with the specification limits. Summary of common Blood transfusion issues and frequent Blood transfusion issues cited by inspections of various regulatory authorities have been enlisted and discussed. Blood-related issues can end the health of the people who were undergone this process; most of these majorly occurring issues are avoidable with appropriate oversight and controls. Steps to be taken by the working committee members around the world who were facing this issue can be avoided by following recommendations and guidelines to avoid blood transfusion and related issues that have been enlisted and discussed.

SUMMARY:

In recent years there has been a significant increase in the risk of blood transfusion and lack of confidence among the public because there were many issues with the infected blood transfused and causes life-threatening diseases. Blood transfusion was also a life-saving process for the patient. So there was a lack of regulatory compliance. With consideration of the importance of Blood transfusion issues in one's life, a detailed study has been carried out for Implementing Haemovigilance in National and International basis with support on Regulatory authorities. The study determines the understanding of this programme and represents there was many adverse events were listed by determining the root causes after performing the analysis program.

CONCLUSION:

Throughout the overall basis of this programme around the world that there were many technical challenges were involved in these implementing criteria to bring out a successful measure and make it a common standard. Since there were benefits in the Blood transfusion, similarly there were also risk factors were involved due to sensitive characteristics of this system. Some of the unavoidable risks became a crucial part of this programme where the errors were occurred both in the donor side and also recipient side, by not noticing the key factors that have evolved in this process, with the presence of working staff and responsible persons itself.

Therefore ensuring the safety is a major task and it is important to any aspect of the organization as the consequences of this getting it wrong are very close and it will take a long time to rebuild the trust. So there should be careful monitoring for implementing this system as effective in International and National basis by considering the factors and issues involved overcoming the challenges. Along with those case studies which were obtained from the reports of the patients, who were faced with adverse risks from the blood transfusion was showing that there are significant deviations from the protocols and categorized the individual errors that occurred in particular issue aspects. From the overall study basis, there should be key recommendations which were given based on the study on errors that have occurred frequently. Based on the recommendations and applicable solutions, the Implementation of Haemovigilance around the world in International, as well as a National basis, will become successful.

ACKNOWLEDGMENT:

Sincere thanks to the Blood bank, Government Hospital, Ootacamund for allowing me to conduct research.

CONFLICTS OF INTEREST:

None

REFERENCES:

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Received on 31.12.2019 Modified on 11.02.2020

Research J. Pharm. and Tech. 2021; 14(2):701-704.

DOI: 10.5958/0974-360X.2021.00123.2