Managing and validating laboratory information systems greek fraternity dating
The worksheet should also include an area for the tester to document pass or fail, the name of the tester, the date of testing, any problems found, and supporting documentation.
During the validation process, supporting documentation such as screen prints or system reports may be collected as proof of the success or failure of the test case.
To assist in the development of scenarios, develop test tables to outline every scenario and the expected outcome (see Tables 2-5).
Table 2 is an example of a test table for a situation containing only one variable.
Regulatory agencies Both the Food and Drug Administration and Health Care Financing Administration have regulations dealing with LIS validation.
Several voluntary accreditation agencies also require computer validation, including the College of American Pathologists, the Joint Commission of Health Care Organizations, the Commission on Office Laboratory Accreditation, and the American Association of Blood Banks.
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.
These computerized elements in a compliance plan, such as test utilization monitoring, accurate billing, and record retention, require computer validation.
Prospective validation is the process of validating a new information system or a new feature or function of a system that has not been previously used in the organization.
This type of validation can include major upgrades from the LIS vendor, such as upgrading from a version 6.0 to a version 7.0.
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.