ABSTRACT
The validation of the results is defined as the review and verification of the coherency and likelihood of the whole results of the examination for a patient, taking into account needed clinical data, uncertainty of measurement and anteriority's as well. The signature of the authorized person certifies this validation according to the requirements of the French regulation and ISO standard as well. Recommendations are given for the organization of this step specially for duty periods and in case of utilization of an expert system software. Requirements about the content, the release and the signature of the reports are given. A quality indicator applied to the control of the validation process is proposed.
ABSTRACT
The requirements related to post-examination phase (chapters 5.7 and 5.8) and to advisory services (4.7, 5.1.4 et 5.1.12) of the standard ISO 15 189 and requirements of the French regulation, as included in the COFRAC document SH REF 02, are applied into actions to display, documents to write and to make available and traceability to ensure.
ABSTRACT
The main nonconformities enumerated to facilitate consensual codification. In each case, an action is defined: refusal to realize the examination with request of a new sample, request of information or correction, results cancellation, nurse or physician information. A traceability of the curative, corrective and preventive actions is needed. Then, methodology and indicators are proposed to assess nonconformity and to follow the quality improvements. The laboratory information system can be used instead of dedicated software. Tools for the follow-up of nonconformities scores are proposed. Finally, we propose an organization and some tools allowing the management and control of the nonconformities occurring during the pre-examination phase.
