Attorneys who specialize in medical negligence/malpractice need a clear concept of the enormous significance of the diagnostic medical laboratory in highly critical cases. This is true for two reasons. First, many people do not realize that nearly 70 percent of all medical diagnoses are made based upon data produced by the clinical laboratory derived from physical specimens collected from the patient.

Second, a great proportion of these tests are of high technical complexity and they change rapidly due to newer tests and testing devices continually becoming available. This allows little time for either attorneys or physicians to become comfortably familiar with techniques or applications, respectively. Time is not their friend because they are struggling to learn and adjust, and it is certainly never on the patient’s side, and therein lies the conflict. Also, if laboratory tests and procedures are not conducted with high precision and within carefully defined limits, the data and results could cost a life or be as worthless as yesterday’s newspaper. They could also devastate and nullify a meticulously prepared personal injury suit if they are misinterpreted.

Attorneys who specialize in focusing upon medical laboratory error and how these shortcomings impact the health and lives of patients genuinely need to know the rules and procedures involved in the progress of clinical lab test specimens from the point of their being ordered to the results being reported to responsible medical personnel.

Pre-Analytical and Analytical Testing Phase

Extremely rapid change in diagnostic technology paints the backdrop against which diagnostic error has always occurred in one manner or another. Laboratory professionals break these errors down as follows. They are known as pre-analytical (ordering, collection and accession or logging-in of specimens), analytical (actual testing or analysis of specimens) and post-analytical (reporting out of results, calling ‘Urgent’ or ‘Critical’ alert if deemed necessary, and physician’s action based on interpretation of lab data results).

Most errors occur in the pre- and post-analytical period, that is to say before or after the diagnostic test is actually performed. Examples of pre-analytical error would be the following:

1. Mislabeling of a specimen

2. Collection of blood in the wrong type of tube (sounds like nothing, but this is a terrific “no no!”

3. Losing a specimen

4. Delayed receipt of a specimen

5. Non-refrigeration of a specimen that requires it

6. Freezing a specimen that is not supposed to be frozen

7. Submitting a hemolyzed blood specimen

8. Logging in a specimen incorrectly or not at all

9. Re-labeling of a specimen

10. Collecting a specimen from the wrong patient, and one could go on endlessly.

ALL of these specimens are invalid, and judgment and outcome of the case could depend on the results of that specimen and its validity. Putting it more succinctly, the health and well-being of a child, a mother, or any patient you wish to describe is dependent upon meticulous actions at each stage of analysis of each laboratory specimen, and precision is essential at each stage.

The analytical phase is when tests are actually being performed on clinical specimens and, interestingly enough, fewest errors of all occur during this period. Laboratory personnel are highly trained individuals and usually do not make this type of mistake, although it does happen. When it does, it is usually because the individual is overly tired, overworked and stressed out. Administration and laboratory managers have gotten into difficulties by pushing personnel into performing far too many tests during a shift, resulting in contamination of either microbiological or other specimens, yielding false positives and occasionally false negatives. Diagnostic laboratory work is precise and must not be batched to an extreme because it will suffer as a result in terms of accuracy, and the outcome is either useless or worse yet, dangerous for the patient, if it is not accurate. A number of false-positives for tuberculosis have come about over the years in this manner because technicians may have been attempting to handle too many specimens in too short a time.

Post-Analytical Phase

So what happens when the specimen successfully passes the pre-analytical phase, the analytical phase and something risky/lethal/potentially lethal is seen and recorded but NOT urgently reported and the patient dies or sustains grave harm? Example: The presence of nucleated red blood cells on blood smears of patients usually means that the patient either has impending sepsis (blood poisoning due to bacteria growing in the blood stream) or cancer. In a documented circumstance, the tech failed to urgently report it, the physician failed to review the patient’s lab results before she was released and subsequently died roughly 48 hours later of sepsis secondary to necrotizing fasciitis. Who was at fault…the poorly trained bench tech? The lab director? The physician?

In another circumstance, in a non-licensure state, a not well-educated laboratory technician grew the infamous “flesh-eating bacteria” out of a surgical wound of a patient who was being released the same day that the culture was reported positive. The tech did not “urgently” notify the physician because, since the patient was to be released, the tech failed to see the urgency since the patient would not need isolation precautions. It never occurred to her that the patient was in horrific danger. Several days later the patient self-admitted to another hospital and lost several limbs, barely surviving the bacterial onslaught with his life, all because lab personnel in a post-analytic error failed to comprehend the urgency of the situation.

Thus clearly, there can be a potentially dangerous disconnect between the physician and the data reporting diagnostic laboratory that can create a chasm into which the patient can fall with no safety net. The alert medical malpractice attorney must be aware of these checkpoints along the way between specimen collection and the responsible reporting of vital clinical data upon which health and sometimes life itself depend.

In closing, there will be times when an a clinical laboratory expert will be able to help sort things out and provide advice as to which types of data will be most reliable in assisting with a particular case. Some avenues are worth pursuing with regard to laboratory testing devices and methodologies and some are not. An expert will almost certainly be able to provide guidance in this technically complex field that is rapidly changing. Remember that assistance is available.

TASA Article Disclaimer

This article discusses issues of general interest and does not give any specific legal or business advice pertaining to any specific circumstances.  Before acting upon any of its information, you should obtain appropriate advice from a lawyer or other qualified professional.

This article may not be duplicated, altered, distributed, saved, incorporated into another document or website, or otherwise modified without the permission of TASA. Contact for any questions.

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