The commission directed Vijaya Diagnostic in the city to pay ₹50,000 to a patient for erroneous diagnostic reports of D-dimer high.
The commission directed Vijaya Diagnostic in the city to pay ₹50,000 to a patient for erroneous diagnostic reports of D-dimer high.(Creative Commons)
The District Consumer Disputes Redressal Commission in Hyderabad has directed city-based Vijaya Diagnostic to pay ₹50,000 to a patient for erroneous diagnostic reports of D-dimer high.
When the Covid-19 pandemic was at its peak, many people around the country tended to visit testing labs not to confirm whether they were Covid-19 positive or negative, but also for health markers to know about their health conditions if they are Covid19 positive.
One of the markers was the D-dimer test. Having a high D-dimer level in your blood can be a sign of a blood clotting disorder.
This is because the level of D-dimer can rise greatly when there’s significant formation and breakdown of blood clots in the human body.
During the Covid-19 pandemic, many patients’ D-dimer values were quite high, and to resolve the issue, they were treated with steroids.
The complainant, P Nagarjuna Reddy, a 31-year-old resident of Musheerabad, went for tests — including for D-dimer — at Vijaya Diagnostic in the Punjagutta Officers Colony on 16 April, 2021, as per his doctor’s instructions after testing positive for the Covid-19.
After 36 hours of giving the sample, he received test results showing a D-dimer value at 895 ng/ml — considered a very high level.
The doctors then advised strong medication to him, including blood thinners and steroids, he said in the petition.
The complainant went for the D-dimer test again 18 April, and he received the result the next day, in which the value of D-dimer was 3,397 ng/ml — an abnormally high amount.
Accordingly, the doctor increased his medication, but questions cropped up about the high levels in the D-dimer test reports despite strong medication, said the complainant.
The complainant on 19 April night went for the test yet again, but this time in another diagnostic lab, and the report showed readings at 340.58 ng/ml, which was strikingly low compared to the report given by Vijaya Diagnostic Centre earlier in the day.
When the complainant contacted Vijaya Diagnostic Centre, one of the officials told him that “either the sample collected was delayed or the excessive load on their system would have caused the delay and errors”.
The complainant further submitted that the test repeated on 22 April at Vijaya Diagnostic showed a further decrease in the reading to 240 ng/ml.
“I was put at a high risk of unnecessary strong medication based on the results of the D-dimer wrongly reported by the Vijaya Diagnostic, resulting in significant weight gain due to the steroids and other strong medicines used during the treatment,” alleged the complainant.
Vijaya Diagnostic Centre contended that the high values of D-dimer were not unexpected in cases where the patients were Covid-19 positive.
On 22 April when the value was very low, it was due to the treatment, it said.
“D-dimer being a marker for inflammation, coagulation and fibrinolysis tends to fluctuate and the values are expected to decrease with appropriate treatment,” said Vijaya Diagnostic Centre in its submission to the consumer commission.
It further contended that it had done the D-dimer test following satisfactory quality-control protocols and that there was no deficiency of service on its part.
The consumer commission, after submissions from both sides, observed that the laboratory claimed to have done the D-dimer tests by the Chemiluminescence Immuno Assay (CLIA) method.
“Whereas, the National Accreditation Board for Testing and Calibration Laboratories (NABL) states that the lab does not have accreditation for the D-dimer test by Chemiluminescence Immuno Assay (CLIA) methodology, which is a deviation as required for the assessment of the quality and competence for conducting the D-dimer test by CLIA methodology,” observed the commission.
The commission also observed that the lab claimed that it released the D-dimer report after correlating with other relevant clinical parameters like CRP/LDH, “but there is no evidence on record” that would substantiate this claim.
Further, the commission said that the erratic variation in the D-dimer results of the complainant released within six days were found erratic as per the clinical analysis, and and that there was no evidence adduced by the lab that it followed the standard operating procedures in compliance with the regulations.
“The lab is liable to make good for the loss and mental agony suffered by the complainant due to erroneous diagnostic reports resulting in indiscriminate medication,” said the commission.
In its order, the commission said that the unnecessary tension and suffering caused to the complainant due to the negligence and deficiency of service on the part of the Vijaya Diagnostic considering, he was entitled to a reasonable compensation of ₹50,000 along with ₹10,000 for the costs of litigation.
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