Examination Results Dr. W. Huisman Cairo, November 21th 2012

5.6 Assuring quality of examination procedures (2 e edition) 5.6 Ensuring quality of examination results in 3 e edition I will follow 3 e edition. No essential changes in content

5.6 Ensuring quality of examination results General Under defined conditions Appropriate pre and post examination processes shall be implemented In my opinion this intends to indicate that results should only be produced on samples which were treated according procedures No fabrication of results Quality control General The laboratory shall design quality control procedures that verify attainment to intended quality of results. With quality control here is ment: internal quality control

5.6.2 Quality control Quality control materials Material that react as close as possible to patient samples Frequency based on stability of procedure and risk of harm from an erroneous result (no frequency stated in standard) Choose concentrations near clinical decision levels, if possible Choose control material from an independant party Quality control data Procedure to prevent release of patient results as quality control fails If quality control rules are violated results shall be rejected, samples re/examined after correction, and look back procedure for previous samples performed

5.6.2 Quality control Quality control data Data shall be reviewed at regular intervals to detect trends. If they occurr this should lead to preventive action Statistical and non/statistical techniques for process control are preferred Rather familiar are the Westgard rules 1x 3sd 2x 2sd 4x1sd 10x same side of mean Most important they are applied before release of result

Quality control general No fixed rules about frequency Look back after failed result Intended sd or cv shall be documented by the laboratory and acceptable required value is preferentially dependent upon internal biological variation or stated in relation to clinical need Immediate action on violation In relation with short turn around time for some results all relevant personell shall be familiar with the rules All violations and restoration actions are documented

5.6.3 Interlaboratory comparisons Participation Participation appropriate to the examination and interpretation of the results. The laboratory shall monitor the results and set up corrective actions when predetermined performance criteria are not fulfilled Documentation of participation including instuctions for participation and criteria which can differ from programme Provide clinical relevant challenges and where possible include the whole process

5.6.3 Interlaboratory comparison Alternative approaches Whenever interlaboratory comparison is not available the laboratory shall develop other approaches to provide objective evidence that the results are acceptable Whenever possible appropriate materials shall be used Certified reference materials Samples previously examined Materials from cell or tissue repositories Exchange of samples with other laboratories Control materials that are tested daily in interlaboratory comparison programmes Accreditation bodies have sometimes guidance documents in relation with use of external quality control

5.6.3 Interlaboratory comparisons Analysis of interlaboratory comparison samples Integration in routine workflow Examination by routine personell No communication with other laboratories No refering of these samples for confirmatory examinations before submission, even when this is done for patient samples These samples can be used for obtaining uncertainty of measurements

5.6.3 Interlaboratory comparisons Evaluation of laboratory performance Performance shall be reviewed and discussed with relevant staff When predetermined performance criteria are not fulfilled staff shall participate in the implementation and recording of corrective action. The effectiveness of this action shall be monitored. The returned results shall be evaluated for trends that indicate potential nonconformities and preventive action shall be taken

5.6.4 Comparability of examination results Procedures for comparing results on patient samples with different instruments, procedures, sites Laboratory has procedures about acceptibility of the difference and starts actions when limits are superseeded Laboratory notifies users about any difference in comparibility and discusses any implication for clinical practice. This is also the case when examination methods are changed Laboratory documents, records and expeditously acts upon the comparison results. Problems identified and actions recorded