A COMPLEX Decision
When a newer model instrument is acquired that replaces an older model, several considerations should have been taken into account, including cost per test, operator time and involvement, processing time, maintenance and calibration requirements, and result reporting systems. But that is not all. It is common practice to substitute reagents manufactured by another company that are compatible with the instrument, as a way of saving money and lowering the cost per test. Of course, this is predicated on validation studies allowing this.
I recently came across an interesting case, where a laboratory did just this, on the assumption that what applied to their original instrument, was equally applicable for their replacement; it was, but with a twist.
Here is the story:
This laboratory had always operated as moderately complex; the qualifications of the staff, including education and experience, met CLIA standards; all other mandated positions, including laboratory director and technical consultant, were also in compliance. The laboratory had, (for a number of years), a chemistry analyzer in which the reagents supplied by a different manufacturer were categorized as moderately complex for most of the tests performed on it; though some other tests available were high complex. The laboratory only performed testing for the moderate complex analytes, thus remaining in compliance.
However, recently, they decided to upgrade to a newer model; the name was the same, except the newer model had a Plus added to the name. The lab assumed the testing complexities were the same. However, it was later discovered during a survey (and subsequently corroborated by the reagent manufacturer) that the same outside reagents provided for this model of instrument had not been submitted for moderate complexity categorization by the FDA, and therefore all tests performed using these reagents were (by default) high complexity.
This created an immediate crisis for the lab: the lab director, technical consultant and testing staff were not qualified for high complexity testing. The corporate owners of the lab had to immediately cease all testing on this instrument (severely impacting its operation), and determine the next course of action: replace the instrument, or replace personnel. Ultimately it chose the latter, from the lab director on down. Also the performance specifications that had been performed upon installation did not meet high complexity requirements, to include verification of analytical sensitivity and specificity.
Thus, any assumptions about a newer model instrument based on the previous model can be hazardous to your operation; you must check everything.