Ensure quality and competence in your medical laboratory by securing ISO 15189 accreditation. Learn how to deal with Advisory services in ISO 15189.
Activities related to the interpretation of medical examination results are, together with analytic and metrological activities, the reason of clinical laboratories. Nevertheless, there is a certain controversy about when and how some activities should be performed or rather executed. For this reason, advisory services in ISO 15189 accreditation were introduced.
Appropriate laboratory professional staff shall advise on the choice of examinations and use of the services, including repeat frequency and required sample type. Where appropriate, an interpretation of the results of examinations shall be provided.
There should be regular documented meetings of professional staff with the clinical staff regarding the use of laboratory services and for consultation on scientific matters. The professional staff should participate in clinical rounds, enabling advice on effectiveness in general and individual cases. Furthermore, the laboratory has an additional responsibility to ensure that, as far as possible, the examinations are correctly interpreted and applied in the patient’s best interest. Specialist advice concerning the selection and interpretation of examinations is part of the laboratory service.
However, ISO 15189 neither clarifies which activities should be done to satisfy the advisory service requirements nor how these activities should be audited. Therefore, it would be reasonable that clinical laboratories seeking accreditation for compliance with ISO 15189 include at least the following advisory service activities:
- To implement a system of information dedicated to requesters about the interpretation of examination results;
- To implement a system for immediate reporting of exceedances;
- To take care of the consultations from requesters on the choice or interpretation of examination results;
- To collaborate with requesters in preparing clinical protocols, defining cut-off points, deciding critical (alert) values for immediate notification, assessing the diagnostic accuracy of laboratory examinations, assessing laboratory-related outcomes, etc.;
- Add interpretative comments to laboratory reports when this activity has been agreed upon. That is to say when in the catalogue of services, it is indicated that the results shall be accompanied by a diagnostic comment or any other type of interpretative comment.
Consequently, the audit of advisory services in ISO 15189 should verify the existence of the following:
- A system of information dedicated to requesters about the interpretation of examination results;
- A list of critical (alert) values readily available to laboratory staff;
- Records containing exceeded values;
- Records containing requests for advisory service (received and answered);
- Records containing activities in cooperation with requesters described in point 5 above;
- A list of those laboratory examinations where it has been agreed that their results shall be accompanied by a diagnostic comment or any other type of interpretative comment;
- An interpretative comment in every clinical laboratory report containing any laboratory examination in the list described in point (f) above. The present proposal may help both clinical laboratories seeking accreditation for compliance with ISO 15189:2003 and accreditation bodies in dealing with such an important