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Managing and validating laboratory information systems

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.

These computerized elements in a compliance plan, such as test utilization monitoring, accurate billing, and record retention, require computer validation.

Depending on the results of a test, TESTRESULT1, another test may be ordered.

After considering all of the possible situations to be tested, the test cases can be listed.

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.

For example, in Table 3, we combined the test case number with Sequential numbers for additional pages of information.

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.

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.

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To assist in the development of scenarios, develop test tables to outline every scenario and the expected outcome (see Tables 2-5).