Service of AIS blood - the Transfusiology Automated Information System (TAIS)

The service of blood integrates a set of the organizations which are engaged in procurement, processing, storage of donor blood and its components. The most part from them – research institutes, blood transfusion stations and departments of blood transfusion in hospitals and so forth. Control of their activity is exercised by FMBA of Russia. The exact quantity of the points preparing blood or using it to call difficult because of permanent reorganization in medical institutions. By estimates of specialists, the first – about 500, the second – about 1500^[1].

As a common information space of Service of blood was created

The first mentioning of need of creation of uniform information base of donorship contains in the act of the Russian Federation of 6/9/1993 No. 5142-1 "About donorship of blood and its components". Ten years later, in 2007-2008, during implementation of the national Health project the transfusiology automated information system (TAIS) was developed. It became the central component of Uniform information base of donorship of blood and its components (EIBD) which allows to automate completely process of registration of the donor, his survey by the doctor, blood donation and its components, their subsequent processing according to technical regulations, storages and issues in medical network for clinical use or for production of medicines.

Stages of development of EIBD

• Order of the Government of the Russian Federation No. 465 of June 21, 2008. "About financial provision in 2008 due to allocations of the federal budget of actions for development of service of blood"
• Order of FMBA of Russia of June 24, 2008 No. 218 "About commissioning of automated information system of transfusiology"
• The federal law of July 20, 2012 N 125-FZ (an edition of 3/7/2018) "About donorship of blood and its components"
• The order of the Government of the Russian Federation of 8/5/2013 N 667 "About maintaining the single database on implementation of the actions connected with security of donor blood and its components, development, the organization and promotion of donorship of blood and its components"

2008-2012

Stages of development of EIBD 2008-2012

2013-2016

Stages of development of EIBD 2013-2016

In 2008-2016 on objects of service of blood segments of EIBD – necessary hardware and software systems for fault-free functioning of AIST were developed. In total them 290 were created.

Quantity of segments of EIBD

All information processed in EIBD is protected according to the legislation on personal data protection in the state information systems.

In view of the fact that reserves of blood and its components are strategically important, during creation of EIBD not only questions of transfusion security, but also a question of high fault tolerance were at the center raised. In each point of blood transfusion, both small, and located in the large center of blood transfusion, own, independent segment of EIBD which has own base of donors and can independently function is created. Between segments information exchange via secure channels of communication is organized.

In each subject of the Russian Federation the regional information center – as a rule, this head organization of service of blood in the region through which there pass all flows of information exchange and where the regional base of donorship collects is defined. Regional information centers send data to the federal segment located in the FMBA Blood Center in Moscow. Here will unroll a data processing center of EIBD, analytical services, technical support service, call center, services of interaction with other federal systems and portals function. 83 regions are connected to a federal segment now. Connection of the Crimea and Sevastopol will take place in the nearest future. Regional information centers are also integrated with a number of specialized medical institutions, such as AIDS centers and clinics providing the information about citizens who for health reasons cannot become donors.

Thus a system which under normal conditions on a centralized basis, online performs information exchange about blood donors and its components was created. In case of technical failures segments can communicate in the region or function separately. At the same time all of them are equipped with means of reservation of data.

Since 2012 after most regional information centers was created, based on EIBD a common information space of service of blood which part all participants of this process – from donors to recipients will be is created. Functioning of EIBD is ensured by more than 800 servers and 5,000 automated jobs.

The AIST system inherited all the best from the previous versions, purchased a number of new features and ample opportunities for functional development. It is ready to integration with external systems in the field of health care of both local, and regional, and federal level, and completely corresponds to the existing regulatory base in the field of donor blood and its components.

"The main requirement to a new system was to provide traceability of information on each component of blood "from a vein to a vein" – i.e. from the moment of appearance of the donor on blood transfusion station before its hit to the specific recipient and his post-transfusion reaction", – Andrey Fisher, the head of information technology of the FMBA Blood Center says. Now AIST contains detailed information on donors, their state of health, the blood test taken by them and also on recipients, their clinical records according to Uniform State Health Information System. In 2017 start of new service "Automated Workplace Recipient" which will transfer to a system data on post-transfusion reaction from any external sources is planned.

The center of blood organizes the centralized technical support of the solution which includes ensuring operability of objects, the centralized database and services. Technical support has three levels. Primary information comes to call center which registers incidents by phone and e-mail, and then redirects information to the corresponding specialists in the field of the software or infrastructure. Solution designers participate in the solution of the most difficult tasks. At the end of 2016 the call center processed about 16,000 addresses among which not only incidents, but also requests for completion of the solution. All arrived requests were considered by specially created methodological management.

In 2016 in a system a number of new services appeared. First, it is the organization of SMS mailing from AIST allowing doctors of donor division without quitting the system, to invite the person to donation or a karantinization, to congratulate him on the Blood donor day and so forth. Secondly, an electronic queue which is integrated with the system of transfusiology, and the magazine of prerecording on donation.

The doctors working in AIST had an opportunity within no more than 5 min. on the basis of the data which are contained in the federal database to learn when the donor last time took a blood test what results of his inspection were. At the same time search of donors in a card file is performed on an intellectual basis, i.e. possible typos will be automatically corrected by a system.

Also in 2016 users of AIST began to receive notifications on the forthcoming updating of a system that helps them to plan the work. At the same time they had a possibility of individual preference of the page, including preserving of already placed orders, for example, for blood with specific parameters for the specific recipient. An opportunity to trace the complete history of storage of this or that product – its movement not only from division in division, from the status in the status, but even from the refrigerator in the refrigerator, from the camera in the camera, from a rack on a rack, from the shelf on the shelf, from a grid on a grid was implemented.

In plans for 2017 holding the summer training seminar for users of a system, development of mobile application within implementation of the loyalty program, implementation of the electronic digital signature and upgrade of the module providing connection of all analyzers to a laboratory system. Besides, in the current year it is going to complete integration of a FSIS of EIBD into Uniform State Health Information System regarding data exchange about recipients.

Interface to Uniform State Health Information System:

• Development of SEMD on a hemotransfusion is complete (the structured electronic medical document), MZ Russian Federation is engaged in implementation of SEMD.
• According to software of May 5, 2018 N555 provides interaction (information exchange) of Uniform State Health Information System with EIBD
• FITs EIBD is connected the protected MZ Russian Federation data network

For the purpose of implementation of requirements of Article 20 of the 125th federal law "About Donorship of Blood and Its Components" and point 5 of rules of maintaining EIBD of the approved PPRF No. 667, regarding information transfer about clinical use of blood and its components, it was timely developed and now in medical institutions of different departmental subordination the automated workplace "Recipient" actively is implemented

• Works for a straight line
• Works through an infrastukrtura of Uniform State Health Information System ZS PD MZ of the Russian Federation
• SEMD – in 2017 is developed
• Also the development stage of service which at the federal level will provide data on hemotransfusions from Uniform State Health Information System in EIBD comes to an end (in sootv with regulations on Uniform State Health Information System)

For the purpose of implementation of requirements of Article 20 of the 125th federal law "About Donorship of Blood and Its Components" and point 5 of rules of maintaining EIBD of the approved PPRF No. 667, regarding information transfer about clinical use of blood and its components, it was timely developed and now in medical institutions of different departmental subordination the automated workplace "Recipient" actively is implemented

• Works for a straight line
• Works through an infrastukrtura of Uniform State Health Information System ZS PD MZ of the Russian Federation
• SEMD – in 2017 is developed
• Also the development stage of service which at the federal level will provide data on hemotransfusions from Uniform State Health Information System in EIBD comes to an end (in sootv with regulations on Uniform State Health Information System)

According to the target model (provided on a slide) obtaining information from Uniform State Health Information System will become the main method of information exchange with health facilities as will provide accomplishment of the principle "single information input – reuse" and will reduce costs of health facilities.

So far the automated workplace "Recipient" is used.

2017

EIBD components

Basis of EIBD is the transfusiology automated information system (TAIS). The first version of a system which was used at deployment of segments of EIBD at the initial stage, was written on Visual FoxPro on the basis of widespread in Moscow and still a number of Russian regions of the software product. Together with growth of number of automation objects there was a completion of an existing solution according to statutory requirements of each subject of the Russian Federation and the specific customer. However the unity of approaches, the automated processes and regulations of service of blood in each new version of TAIS was saved.

In 2012 it was accepted 125-FZ "About donorship of blood and its components", and in 2013 – order of the Government of the Russian Federation No. 667 in which new requirements to information stored in EIBD and to ensuring transfusion security were set. With respect thereto in 2014 there was completely upgraded version AIST and the used DBMS. At the same time updating of AIST version on objects of service of blood, their reduction in compliance to the current legislation began. The new AIST version sets new standards of transfusion security. For example, at receipt of information from the AIDS center in the Far East about removal of the citizen from donorship blood and its components in all segments of EIBD will be rejected.

Quantity of segments of EIBD with new AIST version

The module STORK "Laboratory Information System" (LIS) integrates the Services of blood used in organizations analyzers, allows to transfer to them data in electronic and a type and in the same way to receive results of researches. Thus influence of "a human factor" on analysis results is minimized and transfusion safety is ensured. For example, in the doubtful analysis of the donor the movement all of products received from it is blocked.

Further to a system it is going to connect all organizations in which there are departments of blood transfusion, both regional, and federal subordination – by estimates of the FMBA Blood Center, their total number approaches 350.

Structure of a FSIS ""Uniform base of donorship of blood and its components"

The information and analytical system includes a corporate informational portal and also analytical and communication modules. In 2016 it was completely upgraded. First, changes affected the system interface. In it there were full-fledged templates for e-mail mailings, electronic forms of protocols of a transfusion and an opportunity to work with electronic waybills. Implementation of the reference book of the medical organizations approved by the Ministry of Health became a big step on the way of integration with the Single State Information System of Health Care (SSISHC). Besides, the data analysis module was completely processed – now he is capable to provide statistics of federal level.

Public part of EIBD is the I Am a Donor portal. On it information on activity of organizations of Service of blood and development of donorship in regions is placed, the forum works. But the most important – on it the personal account of the donor in which input will require the 16-unit code issued after blood donation is implemented. The personal account contains data on the total number of donations and detailed information on the last – date, type, results of inspection of the doctor and blood tests. It can be unloaded in a format * pdf and to print for private use.

For involvement of the donor on donation, notifications of the donor on need of testing or providing access to a personal account on the I Am a Donor portal are developed and services of SMS notifications function.

The Information Security System (ISS) ensures functioning of a FSIS of EIBD according to the current legislation, first of all 152-FZ and orders of FSTEC No. 17 and No. 21.

Information security system of FMBA

The module of data exchange is intended for integration of a system with external information resources, for example, with Uniform State Health Information System.

Scheme of information exchange of EIBD

Integration into State system of detection, prevention and elimination of consequences of computer attacks

In pursuance of the federal law of 7/26/2017 No. 187-FZ "About security of critical information infrastructure of the Russian Federation", the FMBA Blood Center carried out by FGBUZ categorization of a FSIS of EIBD according to point 2 of "Rules of categorization of the objects of critical information infrastructure of the Russian Federation" approved by the Order of the Government of the Russian Federation of  February 8, 2018 No. 127.

EIBD is categorized as a unit, the categorization of separate objects (regional segments of EIBD) is not required.

EIBD is appropriated the 1st category. According to the appropriated category, it is necessary to all regional segments of a FSIS of EIBD on objects of service of blood on the basis of requirements of Order No. 239 of FSTEC of the Russian Federation to provide existence of an intrusion detection system (IDS) as a part of infrastructure of AIST. As within a FSIS of EIBD are used the protected Vipnet network, it will be necessary to provide existence on Vipnet IDS HSS object.

Categorization also means that EIBD will be connected to the state intrusion detection system (State system of detection, prevention and elimination of consequences of computer attacks) and external competent authorities will exercise supervision over accomplishment by the requirement of cybersecurity. Proceeding from it, objects of service of blood should toughen an order of use of alienable carriers (USB sticks) and not to allow inappropriate use of the automated workplace and servers intended for work with AIST with the structure of EIBD.

2018

2019

2012

The AIS "Service of Blood" received in December, 2012 in Federal Service for Intellectual Property (Rospatent) the certificate on state registration of the computer programs of November 14, 2012.

The medical information system "Service of Blood" automates work of departments of transfusiology, including, is intended for implementation in registry, in workplaces of the head of department, the therapist, staff of department of an expedition, medical procedures. A system provides information maintenance and control of procedures for blood transfusion for prevention of possible human errors. The staff of transfusion departments can use an information system for planning of the work, distribution and selection of components of blood, the analysis of results and complications of transfusion procedures, carrying out scientific research.

The information system "Service of Blood" increases performance and accuracy of work of staff of departments of transfusiology, reduces risks of emergence of human errors on the way of donor blood from the donor to the recipient. According to unofficial statistics, more than 60% of transfusion complications are connected with different human errors which annually become the reason of tens of thousands of death. Thus, implementation of the medical information system "Service of Blood" it is designed to ensure high safety and quality of transfusion therapy.

Notes