Age- and sex-inconsistent results

Medical Laboratory Observer, Dec, 2004 by Daniel M. Baer

Q CLIA '88 sections require an ongoing mechanism for monitoring inconsistent test results. My state/CLIA inspector tells me that the most important of these are age- and sex-inconsistent results, which must be phoned to the physician to signal [possible] child abuse indicated by semen in the urine of a young female or a positive pregnancy test in a young female. I work in a small rural lab, and I have never in my 25-year career seen any age- or sex-inconsistent results. I have instituted inconsistent test results as a monthly quality-assurance (QA) activity, but it seems so futile. I would like to have an annual in-service and record log on age- and sex-inconsistent test results so I can drop this as a monthly QA activity, but I am having trouble finding any information on [these] results that could be presented at such an annual in-service. Can you help with a source?

A I agree with the CLIA inspector that age- and sex-inconsistent results should be brought to the attention of the physician, just as any inconsistent result should be flagged and investigated. Your lab should have a procedure that clearly delineates the process of reviewing the results and notifying the physician of inconsistent results as well as critical values. You have done the right thing in having this as part of your monthly QA activities.

Your experience in finding that there are very few or no inconsistent results is not unusual. After keeping a log and finding that there are no inconsistent results for a long period of time, it is safe to stop the close monitoring, logging, and reporting and focus your QA activities on something with a high yield or risk. QA efforts should be directed toward activities that are high-risk and/or problem-prone. The procedure for dealing with inconsistent results should be kept in place, and the lab staff should be reminded of it from time to time.

Like so many activities that rarely happen, it is unlikely that anyone has compiled a list of age or sex inconsistencies. The nearest thing I can suggest is the list of pediatric critical values published each year in Medical Laboratory Observer's Clinical Laboratory Reference. There are also some books on pediatric laboratory testing that have information about pediatric reference ranges. Mostly, your staff needs to use its knowledge of laboratory medicine and common sense in suspecting an inconsistent lab result.

--Daniel M. Baer, MD

Professor Emeritus

Department of Pathology

Oregon Health and Science University

Portland, OR

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Daniel M. Baer, MD, is professor emeritus of laboratory medicine at Oregon Health and Science University in Portland, OR, and a member of MLO's editorial advisory board.