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Chapter 26

Chapter 26. Laboratory Information Systems. Introduction. The proper management of information related to blood donors, blood components, and patients receiving transfusions is crucial to ensuring the safety and traceability of blood products.

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Chapter 26

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  1. Chapter 26 Laboratory Information Systems

  2. Introduction • The proper management of information related to blood donors, blood components, and patients receiving transfusions is crucial to ensuring the safety and traceability of blood products. • It is necessary to be able to store information in a safe manner and retrieve it in a timely fashion.

  3. Introduction (cont’d) • It is necessary to be able to track a blood component from the time of its donation, through all of the processing steps, to the patient who receives it. • It is also essential to be able to track components in reverse order, from the recipient back to the donor.

  4. Types of Information Systems • Computerized blood bank information systems are available in many different configurations, in three general categories • A highly complex system like that found in a community blood center • A small part of a complete clinical laboratory information system (LIS) • A stand-alone system, usually found in a hospital blood bank or transfusion service

  5. Application Software • In a blood bank information system, application software allows users to perform tasks that are specific to blood bank operations. • In donor centers • Entry of donor demographic information and test results • Confirmation of blood component labeling • Generation of donor recruitment lists

  6. Application Software (cont’d) • In a transfusion service • Searching for a blood component of a particular ABO group • Entering blood component modification information • Issuing blood for transfusion

  7. Databases • One of the most important functions performed by blood bank applications is maintaining a database of donors, blood components, and transfusion recipients. • A database is an organized set of information divided into files and further subdivided into records.

  8. Laboratory Information Systems • The dynamic files contain records related to a specific donor, patient, or blood component. • The static files contain information that is updated infrequently, such as the list of blood products used in the facility.

  9. Databases (cont’d) • Most systems are equipped with both a “live” or production database and a “test” database. • The static files in both databases are identical, but their dynamic files contain different information.

  10. Databases (cont’d) • The production database contains real information, whereas the test database consists of fictitious records. • The test database offers the user an opportunity to practice the applications of the system (and to make mistakes) without corrupting the database containing actual donor and patient information.

  11. Interface Software • Because different information systems communicate in different computer languages, they require an interface that will allow data to flow between the two systems in a controlled manner. • Interface software may be used to allow data to flow between a hospital information system (HIS) and the blood bank system, or the LIS and the blood bank system.

  12. Laboratory Information Systems (cont’d) • Application programs exist for every task. • The kinds of data that must be managed by a particular blood bank information system depend on the types of services provided by the blood bank. • Community blood centers • Hospital transfusion service • Combined services blood bank laboratory

  13. Laboratory Information Systems (cont’d) • The applications utilized at a donor center enable the users to manage the flow of donors and blood products from donor recruitment to distribution of the final products to hospital customers. • Donor Management: identification, contact information, deferments, scheduling • Donor Registration: demographic information

  14. Donation Facility Software Applications • Donation Data: unique identification number, type of donation made, occurrence of a donor reaction, autologous or designated donation • Donor Recruitment: donors with a specific ABO group, other RBC antigen type, or cytomegalovirus (CMV) seronegativity

  15. Blood Component Management Software Applications • Aspects of blood component management software applications include • Component production • Laboratory testing • Label application and verification • Inventory management and product shipping

  16. Transfusing Facility Software Applications • The applications utilized at a transfusing facility enable the user to maintain accurate histories of patient and donor unit testing and ensure the release of compatible blood products for transfusion. • Blood component management • Product receipt and entry

  17. Transfusing Facility Software Applications (cont’d) • Inventory management • Blood component modification • Component status tracking

  18. Patient Management Software Applications • Patient identification, including name and unique facility identification number, previous ABO/Rh type, transfusion history • Order entry, including physician’s orders for blood components

  19. Patient Management Software Applications (cont’d) • Patient testing, including the use of Truth Tables to prevent the release of invalid results such as nonmatching forward and reverse types • ABO/Rh type testing, including comparison of previous and current test results

  20. Blood Component Reservation • The system can aid in the selection of blood components that will satisfy special transfusion needs and are ABO/Rh compatible. • Autologous or designated blood components • Components and units crossmatched or reserved for a patient are linked to the patient’s record

  21. Result Reporting • Information regarding patient test results and any products linked to the patient should be accessible to the patient’s caregivers.

  22. Blood Component Issue • When blood components are requested for transfusion, the system can assist in issuing them in appropriate order, and by updating its inventory status.

  23. General System Applications • System security, including user ID and function restrictions • Quality assurance functions, including blood product utilization information and C:T ratios • Control functions, including process control and decision support

  24. Corrected or Amended Results • When corrections must be made, both the original erroneous results and the corrected results must be clearly specified as such on monitor displays and printed reports.

  25. Regulatory and Accreditation Requirements • Software vendors and users must follow prescribed guidelines to introduce new software. • Vendors must perform thorough validation testing before making software available. • Users must document validation procedures on site before using such a system. • The AABB and CAP have further system validation requirements.

  26. System Management • Written Standard Operating Procedures (SOPs) for every blood bank operation • Archiving of data • Backup of software programs and data

  27. System Management (cont’d) • Computer downtime procedures • Hardware maintenance • Security maintenance • Error detection, tracking, and correction • Personnel training • Validation of new software, databases, or hardware • Risk assessmentwith appropriate validation

  28. Test Plan • The series of exercises that will be used to validate the blood bank software • Each system function that the blood bank will use must be included in the test plan. • A test plan should be created for each function or operation that the computer will perform. • Risk analysis will determine the extent of testing required.

  29. Test Cases • Assess the system under normal operating conditions but must also offer challenges to the system. • Normal testing uses typical blood bank inputs to produce normal, or routine, outputs. • Boundary testing involves forcing the system to evaluate data that are slightly below or slightly above valid ranges.

  30. Test Cases (cont’d) • Invalid test cases assess the system’s ability to recognize and to reject incorrect inputs. • Special test cases are those that make the system react to unusual inputs. • Stress testing involves pushing the system to its physical limits. • Not every type of test case may be appropriate for each function to be tested.

  31. Parallel Testing • Involves running two systems in parallel and comparing the outputs of both • For a blood bank switching from a manual to a computerized system, every procedure would be performed manually and in the computer. • Parallel testing may also be carried out when switching from a previous information system to a new system.

  32. Benefits of Information System Validation • The creation and performance of comprehensive and detailed validation test cases require allocation of significant resources to the project, but the end result, a well-validated blood bank information system, is worth the resource costs.

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