Risk assessment is an important validation point. It is essential to assess the risk that the system poses to the lab’s processes. In this case, the risks posed are very high because the system is used to transmit results that are essential for creating a treatment plan for patients. I will specifically validate the test requisition and specimen labeling process to ensure that the specimen received by the lab tallies with the electronic lab request. I will also validate the accuracy of results reported in terms of adequate verification and proper classification.
It is important to assess the system’s development quality. Although most of the system development has already been done by the supplier, it is important that I carry out an assessment to determine that it is acceptable in the setting of the laboratory by integrating all the activities in the flow process. I will validate the electronic requisition process, specimen labeling, reception at the lab and accession into the LIS and reporting of results. I will test whether the system is capable of integrating barcode technology, HL7, and Auto Fax programs.
It is also important to carry out an access validation. This is done to ensure that the system can be accessed on the server through various stations from which it is intended to be accessed. I will confirm whether the system can be accessed from the physician’s office and by the client services team. I will confirm whether each of these parties is able to create the applicable documents and receive the applicable results.
I would classify this event as a major risk. Failure of bringing to the attention of a physician of a critical result presents a major risk in that these results may not be considered in the treatment plan leading to a poor outcome. As a result, the system will not have met its objectives.