Abstract:The provision of interpretative advice on laboratory results is a post-analytic activity and an integral part of clinical laboratory services. It is valued by healthcare workers and has the potential to prevent or reduce errors and improve patient outcomes. It is important to ensure that interpretative comments provided by laboratory personnel are of high quality: comments should be patientfocused and answer the implicit or explicit question raised by the requesting clinician. Comment providers need to be adequately trained and qualified and be able to demonstrate their proficiency to provide advice on laboratory reports. External quality assessment (EQA) schemes can play a part in assessing and demonstrating the competence of such laboratory staff and have an important role in their education and continuing professional development. A standard structure is proposed for EQA schemes for interpretative comments in clinical chemistry, which addresses the scope and method of assessment including nomenclature and marking scales. There is a need for evidence that participation in an EQA program for interpretative commenting facilitates improved quality of comments. It is proposed that standardizing goals and methods of assessment as well as nomenclature and marking scales may help accumulate evidence to demonstrate the impact of participation in EQA for interpretative commenting on patient outcome.

Quality in healthcare is ideally at an optimal benchmark, but must be at least above the minimal standards for care. While laboratory quality is ideally judged in clinical terms, laboratory medicine has also used biological variations and state-of-the-art criteria when, as is often the case, clinical outcome studies or clinical consensus are not available. The post-analytical phase involves taking quality technical results and providing the means for clinical interpretation in the report. Reference intervals are commonly used as a basis for data interpretation; however, laboratories vary in the reference intervals they use, even when analysis is similar. Reference intervals may have greater clinical value if they are both optimised to account for physiological individuality, as well as if they are harmonised through professional consensus. Clinical decision limits are generally superior to reference intervals as a basis for interpretation because they address the specific clinical concern in any patient. As well as providing quality data and interpretation, the knowledge of laboratory experts can be used to provide targeted procedural knowledge in a patient report. Most profoundly critically abnormal results should to be acted upon to minimise the risk of mortality. The three steps in quality report interpretation, (i) describing the abnormal data, (ii) interpreting the clinical information within that data and (iii) providing knowledge for clinical follow-up, highlight that the quality of all laboratory testing is reflected in its impact on clinical management and improving patient outcomes.

There appears to be a growing debate with regard to the use of "Westgard style" total error and "GUM style" uncertainty in measurement. Some may argue that the two approaches are irreconcilable. The recent appearance of an article "Quality goals at the crossroads: growing, going, or gone" on the well-regarded Westgard Internet site requires some comment. In particular, a number of assertions which relate to ISO 15189 and uncertainty in measurement appear misleading. An alternate view of the key issues raised by Westergard may serve to guide and enlighten others who may accept such statements at face value.

Clinical laboratories should converge on fewer (7-14) rather than more (21-35) process monitors; monitors should cover all steps of the testing process under laboratory control and include especially high-risk specimen-quality QIs. Clinical laboratory stewardship, the combination of education interventions among clinician test orderers and report consumers with revision of test order formats and result reporting schemes, improves test ordering, but improving result reception is more difficult. Risk calculation reorders the importance of quality monitors by balancing three probabilities: defect frequency, weight of potential harm, and detection difficulty. The triple approach of (1) a more focused suite of generic consensus quality indicators, (2) more active clinical laboratory testing stewardship, and (3) integration of formal risk assessment, rather than competing with economic value, enhances it.

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