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).”

Comment – This statement, while boilerplate for manufacturers, makes little sense for most assays. For example, for cholesterol the limit 200 mg/dL (5.17 mmol/L) is universal these days and I doubt that a laboratory would actually conduct a study to present a new limit to clinicians, as a clinician expects assays to conform to this limit. So, the task is that the manufacturer develop an assay with little bias (which they attempt to do and often achieve).

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:

  1. Classify all lab errors as to severity
  2. Establish goals for the rate of errors in each severity category
  3. Measure lab error rates
  4. For assay performance goals (e.g., failure to meet assay performance is a type of lab error under #1), use the new FDA waiver guidance (see essay) to set up goals including
    1. Use of glucose type error grids for each assay
    2. Goals for allowable total error
    3. Goals for limits for erroneous results
    4. Measure results against goals

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

  1. See for example, http://www.beckman.com/customersupport/ifu/cis/389726/AA/EN_CHOL.doc
  2. See: http://www.cms.hhs.gov/CLIA/downloads/qchigh.pdf
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