Storage electronic record keeping

In many circumstances, the supplied system will be based on a standard COTS product and include additional features that are superfluous in the intended context. These features cannot normally be disabled because they are integral to the COTS product. Such redundant features should be included in the Functional Specification, noted as superfluous and, if possible, rendered inaccessible to users within the implemented computer system. Standard features that support compliance, such as audit trails for electronic records, should be used even if not defined within the URS. In such circumstances it may be necessary to make additional design allowances for the inclusion of these features (e.g., for audit trail functionality, extra storage capacity may be required). Standard documentation for COTS products can be referenced by the Fnnctional Specification, if available for inspection, rather than reproduced. Care must be taken to refer to the correct version of COTS documentation and to keep cross-references up to date following any system upgrades. 

The documentation of all aspects of a POCT service has been a major issue for many years, compounded by the fact that often the storage of data in laboratory and hospital information systems has been limited and often inconsistent. Thus it is critically important to keep an accurate record of the test request, the result, and the action taken as an absolute minimum. Some of the issues concerning documentation are now being resolved with the advent of the patient electronic record, electronic requesting, and better connectivity of POCT instrumentation to information systems and the patient record (see earlier discussion). The... 

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