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Lab UV SB Verify

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Universal Storyboard - Result Verification

A 43-year-old man presented to the Emergency Department after suffering 3 episodes of substernal chest pain
associated with transient dyspnea during the previous 2 days, without associated diaphoresis, nausea, or
vomiting. Risk factors included obesity and a history of smoking 1 pack per day for 25 years. Cardiac
hypertrophy was diagnosed one year previously during stress testing, but no perfusion defects existed at
that time. Electrocardiograms with and without pain showed no dynamic ST-T changes. Plain films of the chest
were unrevealing, and a right upper quadrant ultrasound was within normal limits. Laboratory studies
revealed a normal lipase, elevated total cholesterol and triglycerides, and decreased high-density
lipoprotein. The patient’s cardiac Troponin I (cTnI) was initially <0.02 ng/mL, below the level of
detection. An elevated result of 0.10 ng/mL on a subsequent sample prompted the patient’s admission to the
acute cardiology service. The third cTnI value was again undetectable at <0.02 ng/mL. Verification of the
previous elevated value was requested immediately, yielding a new result of <0.02 ng/mL for that specimen.
The laboratory carried out a standard review of quality control results and sources of preanalytical or
postanalytical error. An amended report was issued on the falsely elevated specimen and the patient was
ultimately discharged to follow up without catheterization. Routine monitoring of verification requests
revealed an elevated number for cTnI since a new test formulation was deployed several months previously.
Reports of these results to the test vendor from multiple sites led to reformulation of the assay with
improved performance.

Business Process

Previous system communication patterns do not provide methods for data transfer regarding unexpected or inconsistent results that may indicate error. These kinds of exchanges have in the past been informal, slow, and difficult to track. Requests to verify the accuracy of results, and the results of the verification, should be supported by the fulfillment process because an erroneous result does not fulfill the requestor's needs and interferes with clinical decision-making. Rapid result verification may allow clinical decision-making to proceed with minimal delay or confusion. Verification may take into account many sources of error, including pre-analytical and post-analytical sources as well as analytical problems, and may trigger a standard laboratory process for evaluating these possibilities. The responses to verification requests may be confirmation or modification of a result, and modifications could take the form of result corrections, amendments, or addenda. In addition, verification requests create a standard data object that can be classified, stored, and monitored over time as a method to detect systematic errors and to progressively improve laboratory quality.

The storyboard above is a modificaiton of an actual case. There are numerous examples of testing problems in many different kinds of tests that result in unnecessary hospitalization, unnecessary cardiac catherizations and other procedures, unecessary additional testing, etc. Communications related to these problems need to be formalized as part of the resulting and fulfillment process. As noted in the storyboard, tracking verification requests and their outcomes may be useful in detecting problems at local, regional, or national levels.

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