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Krouwer Consulting
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What does “It’s up to the lab director” really mean This phrase appears quite often in quality articles and usually means that a quality goal or the interpretation of an evaluation result, rather than being specified, is left up to the discretion of the laboratory director. Some examples of use of this phrase (or something close to it) follow: Reference ranges (assay package inserts) Under virtually any reference range section of a package insert, one will find the phrase, “Each laboratory should establish its own reference intervals based upon its patient population (1).”
Standards CLSI has a variety of evaluation protocols which avoid answering the question of how to define goals. Some examples: EP6, Section 5.3 (Linearity) – “The laboratory must determine its own goals for measurement error for every analyte (see EP21).” EP9, Section 7 (Bias) - “Each laboratory should develop its own criteria (in consultation with its medical staff and/or the technical literature).” EP15, Forward (User Determination of Performance) - “First, the laboratory must specify the required performance for the method.“ EP21, Section 4.3 (Total Error) - “Laboratories should thus attempt to establish limits, for which there are many strategies suggested in the literature.” Perhaps if CLSI were to add clinicians to its subcommittees, it would be in a better position to address goals. EQC (Equivalent Quality Control) Recently, EQC has been debated. From the CMS web site regarding EQC, “The laboratory director has the overall responsibility to determine the laboratory’s QC program” (2). What’s missing All of this “It’s up to the lab director” might make sense, but . . . When I have asked lab directors for their quality goals for assays, their response is usually a request for me to clarify the question. Afterwards, the usual response is, do you mean CLIA goals? Now CLIA goals are proficiency survey goals, not goals for patient results (see essay). In other words, the lab directors that I have spoken to don’t have their own laboratory quality goals. Of course, this does not mean that laboratory directors don’t care about quality or that they do not recognize quality problems; however, it does impede measuring quality failure rates and establishing criteria to know when one has devoted enough effort to a quality program. What is needed is for lab directors to establish lab quality goals and evaluate results. For example, the lab needs to:
Setting goals is a lot of work and could be facilitated by standards organizations. This is one reason that lab directors use CLIA goals – they are looking for guidance from regulatory1 providers. Since manufacturers tend to dominate these groups, it remains to be seen if this will be accomplished. 1Organizations such as CLSI have quasi regulatory status, since FDA adopts CLSI standards. Acknowledgement Helpful comments were provided by Glenn Fine, Executive Vice President of CLSI and Luann Ochs of Roche, the chairholder of the CLSI Evaluation Protocol Area Committee. References |