Table 3 Introduction to the functions of the comprehensive information management system

Project Management

Management of scientific research projects to be carried out in biobank

*Examination/Approval

For approval before the warehousing of scientific research projects, users need to upload the research program, Specimen Collection Application Form, Specimen Storage Record Form, Ethical Review Approval, Informed Consent, and other attached materials to initiate online approval, which will be signed and approved by the head of the Scientific Research Office and the hospital leader group.

Establishment

After project approval is completed, the leader of the biobank shall complete the establishment of the project, enter the name, type, number, funding amount, start and end time, source unit and department, project leader, contact information, proposed storage time of the specimen, special requirements for storage conditions of the specimen, pre-treatment condition of the specimen, and upload the approved relevant materials.

Conclusion

After the completion of the project, the project leader shall initiate the closing application and explain how to deal with the remaining specimens, such as launching the destruction process or signing the Extensive Informed Consent to continue to preserve the specimens (depending on whether it is signed before the project is carried out).

*Specimen Information

Management

*Connect with the HIS system and use the registration number or hospitalization number as the unique identification information to capture the basic information and diagnostic information with one key.

Aligned to prepare docking LIS, PACS, and information-sharing

Platform

*Socio-demographic

Characteristics

The donor’s name, date of birth, ID number, hospital registration number, hospitalization number, telephone number, project, and other basic information are recorded, and the Informed Consent uploaded.

*Diagnostic Information

All diagnostic information, including diagnosis time and diagnosis content, is captured from the HIS system and can be manually updated at any time.

*Family Information

Related information of children and spouses can be added, for example, information of children and spouses can be added to the birth defect cohort, which is convenient for the study of genetic diseases in some families.

Specimen Management

Mainly used for the staff of the biobank to classify, store, retrieve, outbound and return the processed specimens

Space Management

The space management of the deep low temperature refrigerator, liquid nitrogen tank, wax block cabinet and other storage equipment and the storage space allocation of projects.

Specimen Collection

The types of specimens collected are mainly from birth defects, and included other types of specimens, which are divided into blood, tissue, and body fluids. The second level is divided into peripheral blood, umbilical cord blood, umbilical cord, placenta, fetal membrane, tumor tissue, adjacent tissue, normal tissue, amniotic fluid, urine, alveolar lavage fluid, and vaginal secretions. The third level is divided into serum, plasma, whole blood, maternal placenta, fetal placenta, intermediate placenta, amniotic fluid supernatant, and amniotic fluid precipitation. The fourth layer is all kinds of cells. The fifth layer is DNA, RNA, and protein.

Specimen Reception

After processing and packaging, the specimens are associated with the corresponding donors and the corresponding projects, and labeled in accordance with the sequence and coding rules, and then put into boxes, shelves, and storage. The label is designed to be encrypted according to the coding rules, and no patient privacy information appears.

Inventory Retrieval

Mainly used to query the sample type, quantity, location, and donors before stock out.

Specimen Distribution

Mainly used for ex-warehouse of specimens when they are used or destroyed. It is required to submit the Application Form for Ex-warehouse or Destruction of Specimens, the Letter of Commitment for Use of Specimens and other attachment materials and to initiate the ex-warehouse application.

Specimen Return

The restorage of the remaining specimens after use, and automatically recording the number of freeze/thaws.

*Quality Management

Management of all processes including project approval and the quality control of the life-cycle management of specimens and their information including collection, preservation, output records, utilization, or destruction.

*Data Query

Includes inquiry functions such as examination and inquiries on approval records, specimen information, pre-treatment condition, receipt/issue/return record.

*QC Records

Mainly used for quality control personnel to upload quality control schemes and overall quality control results including the date of quality control, sample information, related pictures (DNA/RNA/ protein electrophoresis pictures, etc.).

*Destruction Record

Used for quality control personnel to record the types, quantities, items, reasons for destruction, methods of destruction, and related picture records of specimens destroyed.

*Account Log

All account operations will be recorded for quality and safety traceability of specimens and their information.

System Settings

Account and Operational Limits of Authority management of the biobank management system, and the custom Settings in the system can be changed freely according to the actual usage requirements, which fully reflects the design space concept of QbD

Account Creation

Create a user account and password.

Role Assignment

Assign roles to new accounts and set different permissions for each role. The head of the scientific research office and the leader of the branch in charge of the hospital have the permission to sign and approve, view the scientific research projects in the database, collection statistics of specimens, and so on. The head of the biobank has authority for partial approval, scientific research project management, specimen information management, specimen management, system setting, and quality control management. The biobank information administrator has authority for specimen information management, specimen management, handling the notification of entry application and exit application, and so on. The specimen administrator of the biobank has the permission for specimen management. The quality control manager of the biobank has authority for quality control management. The project leader has the authority to initiate project approval, project conclusion, donor information inquiry, specimen entry application, inventory retrieval, specimen exit application, and return application.

*Custom Fields

Customize settings or adding comments for some special specimen types, storage schemes, processing capacity, and so on. The approval process can be changed under specific circumstances.