Posted by Sten Westgard, MS
For those watching the European news these first six months of 2013, there have been rapid developments in the area of traceability. Companies have started adding traceability claims prominently to their advertising, in direct appeal to consumers. And the consumers have responded by preferring products that have established chains of traceability.
Do you think we're talking about the laboratory? Or something else?
That's right: the hamburger has gone the way of traceability. Customers are now quite interested in knowing the full chain from burger back to the farm.
Of course, it's not hard to understand why. The recent horsemeat scandal - where some "beef" products turned out to actually be 29% or higher horsemeat - has cast a pall on the processed food chain that supplies the major supermarkets. For months, it has not been clear which suppliers, and sub-suppliers, have been at fault. In the meantime, consumers have been worried about what they're eating - and responding to appeals by groceries and restaurants that state, unequivocally, that the food they consume can be traced back to the "truth." In this case, tracing burgers back to the farms where the cattle are raised.
If you had asked me a year ago, which institution was more likely to embrace traceability first: burger joints or laboratories, I would have picked labs. But here's an example where a public scandal shocked consumer sentiment to the extent that major changes are happening rapidly in the food industry.
In the lab, of course, clinicians and patients are shielded from the tracebility, or lack thereof, in their test results. While they assume that their medical tests are of at least the same quality as their hamburgers, they might be surprised to know that some of the tests being run have little to no traceability at all. In other words, some of our tests are worse that hamburgers now. Except luckily it's not horsemeat contaminating the test.
But it's certainly no comfort to know that there might be horse**** in some of our testing numbers. If our patients understood this, they'd be just as outraged about labs as they are about burgers. Woe unto us if we don't fix our methods and our labs before a similar scandal rocks the confidence our patients place in our quality.
UNIFORM PATIENT CARE DEMANDS WHOLE TRACEABILITY
By sure, if our tests are traceable, then the patient’s results will be traceable. Though it’s very nice and also very necessary, but it’s not enough.
If it’s supposed that a specific patient be treated the same way regardless of the health-care institute or the practitioner s/he refers, we need a lot more than just the labs’ results being standardized/harmonized via traceability to a reference method and/or material.
To get uniformity in the patients care demands:
Establishing reference methods and materials as the pivotal point so that all the other activities would be referenced to them.
Establishing “Allowable Uncertainty” that could be tolerated in calibrating field methods.
Consider that when we claim a method is traceable, it means that we have calibrated that method via an unbroken chain of methods/materials against the “Master” of the available methods and materials i.e. the reference method/material. But such a claim does not say anything about the degree of the completeness of this process. To offer “Reliable” traceability we have to establish “Uncertainty Standards”, determine calibration uncertainties, and compare those against the standards to judge about the acceptability of the calibrations.
Establishing “Clinically-acceptable” allowable total errors (as have been done for different analytes since long years ago).
Determining “performance characteristics” of the assay methods to calculate the maximum probable error that a result might contain i.e. “Total Error”.
Total error would be the combined effect of three partners: A) Certain Bias (the same traditional bias), B) Probable Bias that is the result of calibration uncertainty and also inevitable shifts in calibration, and C) method’s variation (again the traditional CV).
Programing QC activities based on the quality standards and performance characteristics (the long-life approach recommended by Professor J. O. Westgard).
Researchers must use assay methods with specifications mentioned above, i.e. methods that are reliably traceable, and strictly Quality Controlled, to get traceable conclusions.
Expert organizations must use only such traceable evidence to prepare traceable guidelines/care-maps that contain traceable reference ranges/cut-offs.
Laboratories must assay the patient’s specimens using “reliably traceable” and “strictly controlled” methods equal to those used in the researches to produce traceable results.
And, physicians must interpret the results and make decisions using traceable care-maps to practice traceable medicine.
As we see, uniformity in patient care needs a lot more than just labs to be traceable. It’s necessary that all the people and the activities related to the health care issue to be traceable. In short, to have a traceable health care system, every body and every activity must be “engaged” and “gaged”.
Hassan Bayat, DCLS, Sina Lab (Qaem-shahr, Iran)
Posted by: Hassan Bayat | July 11, 2013 at 05:43 PM