Consultancy in tissue Banking

Global approach for tissues and cells establishments

A full approach consultancy program based on the EQSTB (European Quality System for Tissue Banking) has been created considering the quality and safety key points of each step of the activity.

Legal and regulatory framework analysis, Standard Operating Procedure (SOP’s) development, management planning, specialized training for establishments’ personnel, clean rooms and establishment design, quality systems and audit reports are provided in this program separately or in an integrated approach.

The objective of creating a tissue bank is improving and standardize the performance of the National Transplant in regard to, amoung others , the optimization of the extraction processes and increasing the number of organ and tissues donations for transplantation.

A new age of biotechnology, genetic engineering, regenerative medicine and important breakthroughs in medical procedures and research is dawning. The tissue and cell donation have enabled the development of a health care field which has improved the quality of life of numerous patients. Tissue banking procedures require a wide range of knowledge and skills in order to assure the efficiency of tissue supply, processing and storage, and to ensure that standard operating procedures are maintained throughout the entire process.

teixits

Cooperation programs in tissue banking and advanced therapies:

Global approach for tissue establishment

DTI foundation offers a consultancy program addressed to countries, regions or local institutions to develop a new or improve the already existing Tissue Banks.

The Tissue Bank must be capable of sustaining the health services to provide the therapeutic grafts for all Surgical and Medical Services approved for transplant.

It is one of the very actual hot issues the elaboration of standards of quality and safety for the donation, procurement, testing, processing, preservation and storage of human tissues and cells intended for transplantation use.

A full approach consultancy program based on the EQSTB (European Quality System for Tissue Banking) has been created considering the quality and safety key points of each step of the activity.

Legal and regulatory framework analysis, Standard Operating Procedure (SOP’s) development, management planning, specialized training for establishments’ personnel, clean rooms and establishment design, quality systems and audit reports are provided in this program separately or in an integrated approach.

Close-up of hands of doctors with clipboards, horizontal

Diagnosis study

Data collection and analysis of the current situation

The diagnostic study aims at identifying organizational, structural and educational needs to be analyzed and foreseeing solutions that can be implemented in different phases.

As first step should be identify the local resources, the available staff and the type of Tissue to be processed. Monitoring the adequacy of the territorial space in where the bank will be created, the need for the acquisition of the required equipment and the development of operational manuals in each of the areas of the bank.

Data collection is done by means of the in-situ visits and personal interviews with the stakeholders assessed.

Nurse reading analyzes

Organizational framework

People, processes and financial management

This analysis aims at improving efficiency and effectiveness of creation of Tissue Banks, focusing on the professionals’ involvement and management factors.

Clear medical activities, responsibilities and suitable professional roles are crucial to foster organizations sustainability and development. Counselling on improvement and strategic planning is settled in close collaboration with the local partner.

Customized training is designed for healthcare professionals who work in the tissue bank according with the educational needs identified and adapted in concordance with the areas of involvement; procurement or tissue processing.

Working plan and aspects to be evaluated for tissue bank development

  • organizational aspect of the processes.
  • donor selection process, exclusion criteria, serological and microbiological trials
  • Tissues extraction
  • Tissue processing and tissue preservation
  • Good manufactural practices (GMP) for Tissue Banking
  • Distribution
  • Investment costs, operating costs and profitability
  • Design a training program for the professional staff working in the Tissue Bank

Development of a quality manual and Standard Operating Procedures (SOP)

The evaluated aspects will be grouped in a quality manual which preferably will be stored in electronic format. The areas to be developed will be defined in conjunction with the local team and after the diagnosis of the situation.

DTI experts will offer their knowledge accumulated during several years in collaboration with international organizations that have a great experience in donation and distributions of the graft. In the same way will be offer assistance for the development of SOPs in concordance with the local team and adapted to the local characteristics.

Explaining

Health professionals awareness

Basics knowledge on tissue use for transplantation

To nurture donation positive attitude towards tissue donation, professional motivation to contribute to the process accomplishment and self-confidence to collaborate in any step of the process among health care professionals of the institutions, an elementary level training program on organ donation is conducted by the local responsible of organ donation activity.

Medical Staff Seated In Circle At Case Meeting

Tissue bank audits

Evaluation, improvement, organization

Its aim is to check the accuracy of the application of corrective actions. International and national experts visit the institutions involved to review retrospectively the cases and potential loses and interview the stakeholders of the process. An auditing report is provided with improvement recommendations.

notebook with application form

Combined program

Diagnosis study and TPM professional training in Tissue Bank

This program combines the analysis of the Tissue Bank development providing recommendations for improvement (Diagnosis study) and the professional training according to the local educational needs identified.

Local visits to identify the potential of Tissue Bank developments, and interviews with authorities should be carried out.

Finally a comprehensive report with conclusions and recommendations will be provided.

Developed Projects

BOTUCATU

In Brazil, the Ministry of Health has considered the process of donation and transplant a priority for the government, because of that they have updated the technical regulation of the national transplant system, which wants to improve and standardize the performance of the National Transplant in regard to, among others, the optimization of the extraction processes and increasing the number of organ and tissues donations for transplantation and, therefore, their availability to the population. Specifically on the tissues subject, the National Transplant System seeks to create 10 new multi-tissue bank in the country which could replay to demand on the area.

PORTADA-CONSULTORIA-TEIXITS

Through this project, the University Hospital of Botucatu could offer better services, around the availability of tissue for transplantation and patients that require it at the local and regional levels and it could serve as an example for other similar organizations other provinces in Brazil.

Objectives: The project’s objective is support the University Hospital of Botucatu in Sao Paulo region, for the creation and development of a Multi- tissues bank (cornea, skeletal muscle, skin, heart valves), in regard to :

Improve the current structure of corneas bank for use better this kind of donation.

Determinate the requirements for infrastructure and human resources to implant in Multi-tissues bank in the region, This will improve the access to transplantation of tissues of the population in the province of Sao Paulo.

Contribute to training doctors and technicians in the different processes of a multi-tissue bank, with the objective of improve the professional skills and find the efficiency and quality of the processes developed.

Increase the availability of viable tissue for patients who require theirs in the region.

Methodology: DTI Foundation supported the University Hospital of Botucatu with a well-recognized group of experts in tissue banking, and develop de program implementation consisted in made visits to the hospital to develop in conjunction with local staff the proposed activities and follow-up tasks through videoconferencing: During the first year of the project 4 virtual meetings will be carried out.

The advisory team will provide to the hospital in Botucatu their accumulated knowledge in different international organizations which have been linked for years, each one with a history of hundreds of thousands of donors and distribution of grafts. The experience and the documents produced will be transferred to the tissue bank, University Hospital of Botucatu.