Asian Bioethics Review

285 Commentary on “A Tale of Two Pathologists” Laboratory examinations are an important adjunct in clinical decision-making. Results of laboratory tests can literally be concerned with life and death issues and patients can be grievously harmed by inaccurate and inappropriate laboratory tests! Reports of tragic consequences from laboratory errors illustrate this significance. It is, therefore, incumbent upon a laboratory medicine practitioner to determine the reliability and validity of clinical tests prior to their inclusion in the laboratory’s list of services. Validation of a new test is a complex procedure that includes the evaluation and standardisation of a test method: determining repeatability, relative specificity and sensitivity and doing the statistical analysis of the results. Only when the test has been validated in the particular laboratory where it is going to be adopted can it be appropriately used to help in the diagnosis and management of a disease. This is especially true for molecular diagnostics which are dependent on laboratory personnel competency and training, the availability of state-of-theart equipment, the accessibility of special reagents and appropriate laboratory standard operating procedures (SOPs). All these factors contribute to variability of results from the same molecular test performed in different laboratories. Ideally, each molecular diagnostic method should have been previously published in peer-reviewed scientific literature and should have been subjected to independent trials in other laboratories before one can say that it has received scientific and international acceptance. Pathologist A reported that the clinical test in question has been standardised and validated in the laboratory which originated it and yet the case states, “Currently, the clinical utility of the test in terms of interpretation of results and subsequent patient management is under study in many other laboratories”. It is, therefore, not accurate to assert that it is already “a proven diagnostic method and needs no further research”. The apprehension of Pathologist B and her insistence that “a proper clinical validation of the test be done in the facility before it is launched as a clinical Asian Bioethics Review September 2009 Volume 1, Issue 3 285–287 C A S E C O M M E N T A R Y C o m m e n t a r y o n “ A Ta l e o f Tw o P a t h o l o g i s t s ” M a r i t a V. T. R e y e s A s i a n B i o e t h i c s R e v i e w S e p t e m b e r 2 0 0 9 Vo l u m e 1 , I s s u e 3 286 test” have scientific, professional and ethical bases. As explained in the case, “appropriate laboratory data are essential for clinicians to accurately assess the status of patients’ health, make accurate diagnoses, formulate treatment plans, and subsequently monitor the effects of treatment. The clinician must be able to trust the test results from the laboratory in order to use them for clinical diagnosis and treatment.” This is to protect the patient from being harmed or wronged. Interestingly, it is Pathologist A that argued that each lab starting the test must develop its own protocol based on standard guidelines to establish a sensitive, standardised assay which, he assures the Head of the Department, is the standard practice for any “in-house” clinical test like this one as opposed to commercial tests that have already undergone extensive validation and screening before launch in the market. The difference in opinion between the two pathologists lies on whether the process for establishment and validation of the test falls under the realm of research, and should be written up as a proper study and submitted to the IRB like any research proposal. Pathologist B believes that the assessment of the molecular test will only be possible if the process is clearly defined as a research study where the objective will be to evaluate all the relevant parameters that could affect the end result. This means that the preliminary tests to be carried out are investigational, they would not be reported as lab results and should not...