Retrospective validation is done after an information system is in operational use, for example, whenever changes in federal or state regulations are implemented.
Supporting documentation collected for test case RE1 results could be organized by numbering pages RE1-1, RE1-2, RE1-3.
Tables 4 and 5 are additional scenarios that may be created for developing validation test cases, showing variations in logic and how the expected outcome will differ when multiple variables must be considered. Computer Validation Training Task Force, a coalition of the AABB, ABRA, ARC, CCBC, and HIMA, Computerized System Validation for Blood Establishments Workshop. Chloe Scott is a management consultant with Superior Consultant Company, Inc., and currently resides in Mesa, AZ.
It is important to remember that an information system is more than just hardware and software and that all components of the system require validation.
The components of an information system include the hardware platforms, the application and operating system software, the user-defined database, site-specific policies and procedures for use of the system, user and computer operations training, and ultimately the computer competency of all system users in the organization.
Various federal, state, and other accreditation agencies require computer validation.
Even if they didn't, it's good business practice to validate your computerized systems.[1-13] Think of the implications for an individual's medical care, as well as the goodwill and respect of your organization in the community, should a single incident of a 2.5 mmol/L potassium result be transposed via an instrument interface to a result of 5.2 mg/d.
Also, a validation plan should be developed for each validation project.
The plan should define the scope and objectives of the project, time lines, personnel assignments, qualifications for installation, performance, functionality, and the criteria that will be used to determine system acceptability.
Once a computer system is installed in any healthcare organization, any and all changes to any component of the entire computerized system must be closely monitored and implemented in an organized or "controlled" manner.
Included are changes to normal limits, use of new reagent lot codes or controls, additions of new tests or procedures in the user-defined database, additions of new results in the database, changes to units for any result, changes in reporting format for any result or procedure, removal of any result or test from the test menu from the laboratory, changes in instrument interface software from the instrument vendor, changes in personnel - including new hires, personnel changes within the laboratory, or personnel changes in other departments that use the laboratory information system (LIS) - or changes in software for any other interface (such as an interface to a hospital information system in hospital-based laboratories).
The model compliance plan for clinical laboratories from the Department of Health and Human Services also recommends several elements that require use of a computer system.