Blood Centre Statues

  1. GENERAL PROVISIONS
    • The statutes of the Blood Centre set forth the objectives, organization of work, competence, functions, structure, management, financing and reporting procedures for the Blood Centre, which is a structural unit of the North Estonia Medical Centre’s Diagnostic Clinic.
    • In its activities, the Blood Centre proceeds from legislation, the statutes, good production and laboratory practices, the Blood Centre’s quality manual, the North Estonia Medical Centre’s statutes and other legal acts.
  1. OBJECTIVES OF THE BLOOD CENTRE
    • to supply healthcare service providers with high-quality, safe blood preparations made from donor blood;
    • promoting voluntary, monetarily uncompensated blood donation;
    • provision of immunohaematological reference lab service.
  1. PRINCIPLES OF ORGANIZATION OF WORK AT THE BLOOD CENTRE
    • The basis for organizing the operation of the Blood centre is the statutes, good production practices, Blood Centre quality manual and the Blood Centre activity plan.
    • The internal division of labour at the Blood Centre derives from the statutes and the official duties set forth in the employees’ job descriptions and the orders issued by the Blood Centre director.
  1. COMPETENCE OF THE BLOOD CENTRE
    • The purview of the Blood Centre includes all matters that must be resolved in order for the Blood centre to fulfil its objectives, including:
      • developing the activity objectives and economic objectives for the Centre and presenting them to the director of the Diagnostic Clinic;
      • developing the Blood Centre strategy, quality policy and development of operating principles, and presenting them to the director of the Diagnostic Clinic;
      • developing and coordinating the development plan for the Centre and presenting them to the director of the Diagnostic Clinic.
      • performing other functions that are not in the purview of other structural units.
  1. FUNCTIONS OF THE BLOOD CENTRE
    • collection of donor blood and making preparations from donor blood on the basis of a valid activity licence for production of medicinal products;
    • provision of laboratory services;
    • provision of immunohaematological reference service;
    • serving as a training base for students and medical residents and professional training of physicians and nursing staff;
    • serving as a training base in the field of blood service;
    • serving as a base for developing blood donorship;
    • developing an information system for handling of blood;
    • taking part in applied research programmes;
    • engaging in cooperation with professional associations, healthcare service providers and international organizations;
    • performing other functions arising from legal acts.
  1. STRUCTURE AND MANAGEMENT OF THE BLOOD CENTRE
    • Structural units of the Blood Centre
      • production department;
      • quality control department;
      • quality assurance department;
      • immunohaematology reference laboratory.
  • Management of the Blood Centre
    • The Blood Centre is headed by a director who organizes the work of the Blood Centre pursuant to the North Estonia Medical Centre’s articles of association, the statutes and job description. The Blood Centre director is directly subordinate to the Diagnostic Clinic director.
    • In the temporary absence of the Blood Centre director, the director shall be replaced by the Blood Centre employee appointed by the director.
    • The Blood Centre’s activities in the sphere of nursing are headed by the Blood Centre nursing director, who is directly subordinate to the Blood Centre director.
    • The Blood Centre’s activities in the sphere of quality control and assurance are headed by the Blood Centre quality director, who is directly subordinate to the Blood Centre director.
    • The promotion of blood donorship is headed by the donorship development director, who is directly subordinate to the Blood Centre director.
  • Functions of the Blood Centre director
    • heads the work of the Blood Centre and ensures that the legal acts governing activity are complied with accurately and expediently;
    • organizes briefings, conferences and performance interviews with employees;
    • ensures the timely process of application for activity licences for medicinal product production;
    • ensures that the activities of the Blood Centre conform to the activity licence for medicinal product production;
    • takes part in compiling the budget of the Blood Centre pursuant to the procedure for compiling the budget and is responsible for accurate and expedient compliance;
    • submits to the Diagnostic Clinic director proposals for better organizing the work of the Blood Centre;
    • approves documents pertaining to the organization of work at the Blood Centre, approval of which is not in the purview of the management board or other structural units;
    • gives Blood Centre employees written and one-time oral orders;
    • makes proposals for entering into, amending or terminating employment contracts with Blood Centre staff;
    • makes proposals regarding organization of work, wages, bonuses, and application of disciplinary sanctions and incentives.
  • Functions of the department head
    • heads the work of the department and ensures that performance of the duties imposed on the department is legal, accurate and timely.
    • gives instructions and orders to the department’s employees.
    • supervises department employees’ performance of duties;
    • signs or initials documents prepared by the department in conformity to the administrative procedure, the organization’s manual and the Blood Centre’s procedure for administration of quality and production documents;
    • represents the department in performing its functions and provides opinions and consent in matters in the purview of the department to the Diagnostic Clinic director and other structural units;
    • fulfil other functions arising from legal acts and assigned by the director.
  1. ORGANIZATION OF WORK IN THE PRODUCTION DEPARTMENT
    • Objective of the production department
      • ensure that hospitals have optimal blood component stocks and to ensure the quality, safety and effectiveness of blood components released by the Blood Centre.
  • Basic functions of the production department
    • planning and carrying out blood drives;
    • registration of donors and keeping the donor register;
    • evaluating suitability of individuals as donors;
    • collection of donor blood,
    • making blood preparations;
    • ensuring stocks of blood preparations;
    • preservation of blood preparations and issuing them to hospitals.
  • Management of the production department
    • The production department is headed by the production director.
  • Structure of the production department
    • donor zone;
    • production zone;
    • blood component preservation and release zone;
  • Donor zone activities
    • providing service to and registering blood donors;
    • keeping the blood donor register;
    • summoning blood donors to make a donation;
    • forwarding information on blood donorship to donors and providing consultation to donors in this field;
    • medical examinations of blood donors and evaluating individual suitability to be a donor;
    • collection of donor blood,
    • planning trips for remote blood donations, compiling annual and monthly plans;
    • preparing for excursions and carrying out blood drives;
    • planning apheresis donors and recruiting new apheresis donors;
    • maintaining apheresis donor register and summoning donors;
    • carrying out apheresis procedure;
    • advising blood donors and assisting them in the event of a donor reaction;
    • calling in donors disqualified from donation, advising them and keeping a register;
    • registration of blood donors’ complaints and suggestions.
  • Activities in the production zone
    • planning blood component stocks;
    • preparation of blood components (including cleaning, filtering and irradiating blood components) .
    • preservation of blood components in quarantine storage;
    • withholding and documenting blood components;
    • maintenance and reporting on quarantine storage;
    • labelling and vacating blood components;
  • Activities in the blood component preservation and release zone
    • preservation of blood components in quarantine storage;
    • timely replenishing blood components stocks;
    • handling orders from medical institutions and preparing blood components for transport;
    • releasing blood components to hospitals;
    • maintenance and reporting on storage of ready to use products;
    • registration of hospitals’ complaints and suggestions;
    • preserving, assembling and delivering fractionation plasma to the fractionation facility.
  1. ORGANIZATION OF WORK IN THE QUALITY CONTROL DEPARTMENT
    • Objective of the quality control department
      • to ensure for donors the timely, as-required and high-quality performance of testing of blood components made in the Blood Centre.
  • Main functions of the quality control department
    • testing donor blood for infectious agents;
    • performing testing to test quality of blood components;
    • microbiological testing;
    • immunohaematological testing of donor blood;
  • Management of quality control department
    • The quality control department is headed by the chief specialist of the quality assurance department.
  • Structure of the quality control department
    • testing lab;
    • blood type lab;
  • Testing lab activities
    • performs testing of donor blood for infectious agents pursuant to the procedure set forth in the Blood Centre;
    • collects archival samples of donor blood and is responsible for maintenance of serum archive,
    • determines the total protein content for thromboapheresis donors;
    • performs quality control testing of donor blood pursuant to the procedure set forth in the Blood Centre;
    • performs statistical analysis results of quality control of blood component by each month and by quality indicators for each product;
    • performs microbiological testing of blood components and the working environment pursuant to the procedure set forth in the Blood Centre;
    • performs microbiological testing of disinfection of the venous needle insertion sites;
    • sterilizes in autoclave sterile material in the quality control
  • Blood type lab activities
    • performs immunohaematological testing of donor blood pursuant to the procedure set forth in the Blood Centre;
    • preparing standard erythrocytes;
    • establishing a phenotyping donor register for clinical significant blood types and managing maintenance thereof.
  1. ORGNIZATION OF WORK IN THE IMMUNOHAEMATOLOGICAL REFERENCE LAB
    • Objective of reference lab
      • the objective of the immunohaematological reference lab is to perform immunohaematological testing for patients at medical institutions and carrying out diagnostics on an advanced level, and to coordinate, guide and evaluate in an expert fashion the diagnostics in the field of immunohaematology in all labs in the relevant area operating in Estonia in order to ensure consistent modern quality of diagnostics.
  • Main functions of reference lab
    • performing functions of an immunohaematological reference lab
  • Management of reference lab
    • The reference lab is headed by the director and senior physician of the reference lab.
  • Structure of the reference lab
    • the reference lab;
    • the blood type genotyping lab.
  • Activities of the immunohaematological reference lab
    • performs immunohaematological testing on patients;
    • develops requirements and diagnostics strategy for immunohaematological testing;
    • coordinates, guides and directs diagnostics at relevant labs;
    • determines antigens and antibodies in the clinically significant blood type systems and ensures strategic stocks for Estonia of reagents necessary for identifying them;
    • possesses and applies routine and reference diagnostics in the field of immunohaematology;
    • prepares reference materials and panels;
    • gathers information on various new diagnostic methods and compares them from the standpoint of effectiveness;
    • organizes consultation in the speciality and professional certification, performs relevant training and ins-service training;
    • ensures special matching for medical institutions around the clock;
    • advises and counsels attending physicians in the field of transfusiology;
    • performs expert analysis to identity reasons of post-transfusion reactions;
    • Participates in international comparative experimentation programmes in the immunohaematological speciality.
  1. ORGANIZATION OF WORK IN THE QUALITY ASSURANCE DEPARTMENT
    • Objective of the quality assurance department
      • to ensure functioning of the Blood Centre’s quality system.
  • Main functions of the quality assurance department
    • developing the Blood Centre’s quality policy and quality assurance system;
    • implementing quality elements into the activity of the Blood Centre in cooperation with Blood Centre department;
    • verification of functioning of quality elements implemented into the Blood Centre’s work process, planning corrective activities and analysis of effectiveness of the planned measures;
    • ensuring blood vigilance.
  • Management of the quality assurance department
    • The quality assurance department is headed by the Blood Centre quality director.
  1. PROCEDURE FOR FINANCING THE BLOOD CENTRE
    • The Blood Centre is financed on the basis of budget approved by the board.
    • The use of budgetary resources takes place based on the procedure established by the board.
  1. PROCEDURE FOR REPORTING AT THE BLOOD CENTRE
    • The Blood Centre prepares and submits work reports in harmony with legislation and other legal acts and in accordance with procedure established with the management board.
      • The Blood Centre director submits general work reports to the Diagnostic Clinic director.
      • Reports related to the day to day work of the Blood Centre shall be submitted by departments’ staff to the department head and the department heads to the Blood Centre director.